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NCT Number: NCT02108171

Intranasal Dexmedetomidine Premedication

Most patients with preoperative varying degrees of stress, anxiety, which makes the stress response in patients and affect the normal conduct of anesthesia and surgery.The sympathetic system hyperexcitability prone to cause adverse cardiovascular events and affect postoperative recovery. However, phenobarbital, as the traditional premedication, has less sedative, weak anxiolytic and other shortcomings. Midazolam accompanied by inhibition of respiration,excessive sedation, easily induced delirium,prolonged recovery time and so on. Dexmedetomidine is a highly selective α2-adrenergic receptor agonist, it has sedative, anxiolytic, no inhibition of respiration, and also colorless, odorless, non-mucosal stimulation, nasal drip ease of administration, patient acceptance, comfortable. Therefore, dexmedetomidine as premedication has certain advantages. The purpose of this research is to study sedative effect, safety and the impact of anesthesia recovery period of intranasal dexmedetomidine premedication for suspension laryngoscopy.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guangzhou First Municipal People's Hospital, Guangzhou, Guangdong, China

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About this study

All patients received intranasal dexmedetomidine (1μg.kg-1) or placebo at approximately 45 min before induction of anesthesia.The study drug was prepared in a 1-ml syringe.An equal volume of dexmedetomidine or placebo was dropped into each nostril by a blinded research assistant in the supine position.Automatic sphygmomanometer measure blood pressure.Oxygen saturation and heart rate were measured by a pulse oximeter. Respiratory rate, sedation score and anxiety levels regularly assessed. Patients with general anesthesia, suspension laryngoscopy surgery and postoperative care, standard monitoring are unified.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Surgery:The laryngoscope vocal polyp excision
  • Aged 18 to 60 years old
  • Body mass index (BMI) < 30 kg/m2
  • American society of Anesthesiologist (ASA) I -II

Exclusion criteria

  • The investigator refused to participate
  • Known allergy or hypersensitive reaction to dexmedetomidine or anesthetic
  • With previous history of heart disease
  • Pregnant women; no reliable contraceptive measures in postmenopausal women
  • Preoperative heart rate less than 45bpm; Ⅱ or Ⅲ degree atrioventricular block; ischemic heart disease
  • Taking antihypertensive drugs such as methyldopa, clonidine and other α2 receptor agonist
  • Asthma
  • Sleep apnea syndrome
  • Liver and kidney dysfunction
  • Known to suffer from mental illness
  • Long-term use of sedatives and analgesics in patients

Treatment and study plan

Dexmedetomidine

Drug

intranasal dexmedetomidine 1μg.kg-1,0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia.

Other names: intranasal dexmedetomidine

Placebo

Drug

0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia.

Other names: saline

Primary outcomes

  1. Extubation Time After Intranasal Dexmedetomidine Premedication

    Time frame: 1 days

    The times from stopping anesthetic infusions to adequate ventilation, consciousness and extubation after intranasal dexmedetomidine or placebo administration

Secondary outcomes

  1. Modified OAA/S Scores of Patients Receiving Intranasal Placebo or Dexmedetomidine

    Time frame: 1 days

    Modified Observer's Assessment of Alertness/Sedation scale (OAA/S) scores and 4 point anxiety score of patients receiving intranasal placebo or dexmedetomidine.

    Modified Observer's Assessment of Alertness/Sedation Scale:

    6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking

    1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus.

  2. Heart Rate (HR) of Patients Receiving Intranasal Placebo or Dexmedetomidine

    Time frame: 1 day

    Heart rate (HR) of patients receiving intranasal placebo or dexmedetomidine. HR was monitored in the study.

  3. Number of Participants With Anxiety Score >2

    Time frame: 1 day

    satisfaction using a 3-point satisfaction score (1 = highly satisfactory, 2 = acceptable, and 3 = unacceptable) anxiety levels using a 4-point anxiety score (1 = combative, 2 = anxious, 3 = calm, and 4 = amiable) were collected before intranasal drugs and at pre-induction.

    Anxiety score >2 was considered to be better for the patient.

  4. Anxiety Score of Patients Receiving Intranasal Placebo or Dexmedetomidine

    Time frame: 1 day

    4-point anxiety score:

    • = combative
    • = anxious
    • = calm
    • = amiable. Anxiety score >2 was considered to be better for the preoperative patients.
  5. Systolic Blood Pressure(SBP)of Patients Receiving Intranasal Placebo or Dexmedetomidine

    Time frame: 1 day

    Systolic blood pressure(SBP)of Patients Receiving Intranasal Placebo or Dexmedetomidine.

  6. Number of Participants With Satisfaction Score <2

    Time frame: 1 day

    Patient satisfaction scores using a 3-point satisfaction score (1 = highly satisfactory, 2 = acceptable, and 3 = unacceptable) were collected when patients were discharged from the post-anesthesia care unit (PACU).

    Satisfaction score <2 was considered to be better for the patient

  7. Perioperative Bradycardia Episodes

    Time frame: 1 day

    Bradycardia was defined as heart rate (HR) <45 bpm for more than 10 s.

  8. Perioperative Tachycardia Episodes

    Time frame: 1 day

    Tachycardia was defined as heart rate (HR) >100 bpm for more than 10 s.

  9. Perioperative Hypotension Episodes

    Time frame: 1 day

    Hypotension was defined as systolic blood pressure (SBP) decreased more than 30% of the pre-operative value for more than 1 min.

  10. Perioperative Hypertonsion Episodes

    Time frame: 1 day

    Hypertension was defined as systolic blood pressure (SBP) increased 130% of the pre-operative value for more than 1 min.

Other outcomes

  1. Baseline Characteristic Data (Weight) of Patients Receiving Intranasal Placebo

    Time frame: 1 day

    Baseline characteristic data of patients receiving intranasal placebo The weights of 41 adult patients receiving intranasal placebo

  2. Baseline Characteristic Data (Weight) of Patients Receiving Intranasal Dexmedetomidine

    Time frame: 1 day

    Baseline characteristic data of patients receiving intranasal dexmedetomidine The weights of 40 adult patients receiving intranasal dexmedetomidine

  3. Baseline Characteristic Data (Height) of Patients Receiving Intranasal Placebo

    Time frame: 1 day

    Baseline characteristic data of patients receiving intranasal placebo The heights of 41 adult patients receiving intranasal placebo

  4. Baseline Characteristic Data (Height) of Patients Receiving Intranasal Dexmedetomidine

    Time frame: 1 day

    Baseline characteristic data of patients receiving intranasal dexmedetomidine The heights of 40 adult patients receiving intranasal placebo

  5. Baseline Characteristics (Sex)of Patients Receiving Intranasal Placebo or Dexmedetomidine

    Time frame: 1 day

    Baseline characteristics (sex)of patients receiving intranasal placebo or dexmedetomidine The sex of 81 adult patients receiving intranasal placebo or dexmedetomidine

  6. Baseline Characteristics (ASA Status) of Patients Receiving Intranasal Placebo or Dexmedetomidine

    Time frame: 1 day

    American Society of Anesthesiologists (ASA) status of patients receiving intranasal placebo or dexmedetomidine.

    ASA I: No organic, physiologic, biochemical or psychiatric disturbance ASA II: A patient with mild systemic disease that results in no functional limitation.

    ASA III: A patient with severe systemic disease that results in functional impairment.

    ASA IV: Severe systemic disease that is a constant threat to life. ASA V: Moribund condition in a patient who is not expected to survive with or without the operation.

    ASA VI: Declared brain death patient whose organs are being harvested for transplantation.

  7. Duration From Intranasal Drug Administration to Arrival at Operating Room of Patients Receiving Intranasal Placebo

    Time frame: 1 day

    Duration from intranasal drug administration to arrival at operating room of patients receiving intranasal placebo surgical data of patients receiving intranasal placebo

  8. Duration From Intranasal Drug Administration to Arrival at Operating Room of Patients Receiving Intranasal Dexmedetomidine

    Time frame: 1 day

    Duration From Intranasal Drug Administration to Arrival at Operating Room of Patients Receiving Intranasal dexmedetomidine surgical data of patients receiving intranasal dexmedetomidine

  9. Duration From Intranasal Drug Administration to Anesthesia Intubation of Patients Receiving Intranasal Placebo

    Time frame: 1 day

    Duration from intranasal drug administration to anesthesia intubation of Patients Receiving Intranasal Placebo surgical data of patients receiving intranasal placebo

  10. Duration From Intranasal Drug Administration to Anesthesia Intubation of Patients Receiving Intranasal Dexmedetomidine

    Time frame: 1 day

    Duration of minutes From Intranasal Drug Administration to Anesthesia Intubation of Patients Receiving Intranasal dexmedetomidine surgical data of Patients Receiving Intranasal dexmedetomidine.

  11. Duration of Anesthesia of Patients Receiving Intranasal Placebo

    Time frame: 1 day

    Duration of anesthesia of patients receiving intranasal placebo Duration from anesthesia intubation to anesthesia ending

  12. Duration of Anesthesia of Patients Receiving Intranasal Dexmedetomidine

    Time frame: 1 day

    Duration of anesthesia of patients receiving intranasal dexmedetomidine Duration from anesthesia intubation to anesthesia ending

  13. Duration of Surgery of Patients Receiving Intranasal Placebo

    Time frame: 1 day

    Duration of surgery of patients receiving intranasal placebo Duration from surgery beginning to anesthesia ending

  14. Duration of Surgery of Patients Receiving Intranasal Dexmedetomidine

    Time frame: 1 day

    Duration of surgery of patients receiving intranasal dexmedetomidine. Duration from surgery beginning to anesthesia ending

  15. Modified OAA/S Score of Patients Receiving Intranasal Placebo Before Intranasal Drugs

    Time frame: 1 day

    Modified OAA/S score of patients receiving intranasal placebo Before intranasal drugs Modified Observer's Assessment of Alertness/Sedation Scale (Modified OAA/S score) 6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking

    1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus

  16. Modified OAA/S Score of Patients Receiving Intranasal Dexmedetomidine Before Intranasal Drugs

    Time frame: 1 day

    Modified OAA/S score of patients receiving intranasal dexmedetomidine Before intranasal drugs Modified Observer's Assessment of Alertness/Sedation Scale (Modified OAA/S score) 6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking

    1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus

  17. Modified OAA/S Score of Patients Receiving Intranasal Placebo at Pre-induction

    Time frame: 1 day

    Modified OAA/S score of patients receiving intranasal placebo at Pre-induction.

    Modified Observer's Assessment of Alertness/Sedation Scale (Modified OAA/S score):

    6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking

    1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus

  18. Modified OAA/S Score of Patients Receiving Intranasal Dexmedetomidine at Pre-induction

    Time frame: 1 day

    Modified OAA/S score of patients receiving intranasal dexmedetomidine at Pre-induction.

    Modified Observer's Assessment of Alertness/Sedation Scale (Modified OAA/S score):

    6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking

    1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus

  19. Modified OAA/S Score of Patients Receiving Intranasal Placebo After Extubation

    Time frame: 1 day

    Modified OAA/S score of patients receiving intranasal placebo After extubation. Modified Observer's Assessment of Alertness/Sedation Scale (Modified OAA/S score) 6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking

    1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus

  20. Modified OAA/S Score of Patients Receiving Intranasal Dexmedetomidine After Extubation

    Time frame: 1 day

    Modified OAA/S score of patients receiving intranasal dexmedetomidine after extubation.

    Modified Observer's Assessment of Alertness/Sedation Scale (Modified OAA/S score):

    6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking

    1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus

  21. Anxiety Score of Patients Receiving Intranasal Placebo Before Intranasal Drugs

    Time frame: 1 day

    Anxiety score of Patients Receiving Intranasal Placebo Before Intranasal Drugs. The patients were taught to rate their anxiety levels using a 4-point anxiety score (1 = combative, 2 =anxious, 3 = calm, and 4 = amiable)

  22. Anxiety Score of Patients Receiving Intranasal Dexmedetomidine Before Intranasal Drugs

    Time frame: 1 day

    Anxiety score of Patients Receiving Intranasal dexmedetomidine Before Intranasal Drugs.

    The patients were taught to rate their anxiety levels using a 4-point anxiety score (1 = combative, 2 =anxious, 3 = calm, and 4 = amiable)

  23. Anxiety Score of Patients Receiving Intranasal Placebo at Pre-induction

    Time frame: 1 day

    Anxiety score of Patients Receiving Intranasal Placebo at Pre-induction. The patients were taught to rate their anxiety levels using a 4-point anxiety score (1 = combative, 2 =anxious, 3 = calm, and 4 = amiable)

  24. Anxiety Score of Patients Receiving Intranasal Dexmedetomidine at Pre-induction

    Time frame: 1 day

    Anxiety score of Patients Receiving Intranasal dexmedetomidine at Pre-induction.

    The patients were taught to rate their anxiety levels using a 4-point anxiety score (1 = combative, 2 =anxious, 3 = calm, and 4 = amiable)

  25. Satisfaction Scores of Patients Receiving Intranasal Placebo

    Time frame: 1 day

    Satisfaction scores of patients receiving intranasal placebo. satisfaction was assessed using a 3-point satisfaction score(1 = highly satisfactory, 2 = acceptable, and 3 = unacceptable).

  26. Satisfaction Scores of Patients Receiving Intranasal Dexmedetomidine

    Time frame: 1 day

    Satisfaction scores of patients receiving intranasal dexmedetomidine. Satisfaction used a 3-point satisfaction score(1 = highly satisfactory, 2 = acceptable, and 3 = unacceptable).

  27. Time to Spontaneous Breathing of Patients Receiving Intranasal Placebo

    Time frame: 1 day

    Time to spontaneous breathing of patients receiving intranasal placebo. The time elapsed between stopping anesthetic infusions and adequate ventilation

  28. Time to Spontaneous Breathing of Patients Receiving Intranasal Dexmedetomidine

    Time frame: 1 day

    Time to spontaneous breathing of patients receiving intranasal dexmedetomidine. The time elapsed between stopping anesthetic infusions and adequate ventilation

  29. Time to Consciousness of Patients Receiving Intranasal Placebo

    Time frame: 1 day

    Time to consciousness of patients receiving intranasal placebo. The time elapsed between stopping anesthetic infusions and consciousness.

  30. Time to Consciousness of Patients Receiving Intranasal Dexmedetomidine

    Time frame: 1 day

    Time to consciousness of patients receiving intranasal dexmedetomidine. The time elapsed between stopping anesthetic infusions and consciousness.

  31. Time to Extubation of Patients Receiving Intranasal Placebo

    Time frame: 1 day

    Time to extubation of patients receiving intranasal placebo. The time elapsed between stopping anesthetic infusions and extubation

  32. Time to Extubation of Patients Receiving Intranasal Dexmedetomidine

    Time frame: 1 day

    Time to extubation of patients receiving intranasal dexmedetomidine. The time elapsed between stopping anesthetic infusions and extubation

  33. Predicted Effect-site Concentrations of Propofol After Intranasal Placebo at Tracheal Intubation

    Time frame: 1 day

    Predicted effect-site concentrations of propofol after intranasal placebo at tracheal intubation.

    Propofol was infused intraoperatively to a target-controlled infusion (TCI) plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery.

  34. Predicted Effect-site Concentrations of Propofol After Intranasal Dexmedetomidine at Tracheal Intubation

    Time frame: 1 day

    Predicted effect-site concentrations of propofol after intranasal dexmedetomidine at tracheal intubation.

    Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery.

  35. Predicted Effect-site Concentrations of Propofol After Intranasal Placebo Before Inserting Operative Laryngoscope

    Time frame: 1 day

    Predicted effect-site concentrations of propofol after intranasal placebo before inserting operative laryngoscope.

    Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery.

  36. Predicted Effect-site Concentrations of Propofol After Intranasal Dexmedetomidine Before Inserting Operative Laryngoscope

    Time frame: 1 day

    Predicted effect-site concentrations of propofol after intranasal dexmedetomidine before inserting operative laryngoscope.

    Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery.

  37. Predicted Effect-site Concentrations of Propofol After Intranasal Placebo on Removal of Operative Laryngoscope

    Time frame: 1 day

    Predicted effect-site concentrations of propofol after intranasal placebo on removal of operative laryngoscope.

    Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery.

  38. Predicted Effect-site Concentrations of Propofol After Intranasal Dexmedetomidine on Removal of Operative Laryngoscope

    Time frame: 1 day

    Predicted effect-site concentrations of propofol after intranasal dexmedetomidine on removal of operative laryngoscope.

    Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery.

  39. Predicted Effect-site Concentrations of Propofol After Intranasal Placebo at Return of Spontaneous Breathing

    Time frame: 1 day

    Predicted effect-site concentrations of propofol after intranasal placebo at return of spontaneous breathing.

    Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery.

  40. Predicted Effect-site Concentrations of Propofol After Intranasal Dexmedetomidine at Return of Spontaneous Breathing

    Time frame: 1 day

    Predicted effect-site concentrations of propofol after intranasal dexmedetomidine at return of spontaneous breathing.

    Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery.

  41. Predicted Effect-site Concentrations of Propofol After Intranasal Placebo at Emergence

    Time frame: 1 day

    Predicted effect-site concentrations of propofol after intranasal placebo at emergence.

    Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery.

  42. Predicted Effect-site Concentrations of Propofol After Intranasal Dexmedetomidine at Emergence

    Time frame: 1 day

    Predicted effect-site concentrations of propofol after intranasal dexmedetomidine at emergence.

    Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery.

  43. Predicted Effect-site Concentrations of Propofol After Intranasal Placebo at Extubation

    Time frame: 1 day

    Predicted effect-site concentrations of propofol after intranasal placebo at extubation.

    Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery.

  44. Predicted Effect-site Concentrations of Propofol After Intranasal Dexmedetomidine at Extubation

    Time frame: 1 day

    Predicted effect-site concentrations of propofol after intranasal dexmedetomidine at extubation.

    Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery.

  45. Predicted Effect-site Concentrations of Remifentanil After Intranasal Placebo at Tracheal Intubation

    Time frame: 1 day

    Predicted effect-site concentrations of remifentanil after intranasal placebo at tracheal intubation.

    Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator

  46. Predicted Effect-site Concentrations of Remifentanil After Intranasal Dexmedetomidine at Tracheal Intubation

    Time frame: 1 day

    Predicted effect-site concentrations of remifentanil after intranasal dexmedetomidine at tracheal intubation.

    Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator

  47. Predicted Effect-site Concentrations of Remifentanil After Intranasal Placebo Before Inserting Operative Laryngoscope

    Time frame: 1 day

    Predicted effect-site concentrations of remifentanil after intranasal placebo before inserting operative laryngoscope.

    Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator

  48. Predicted Effect-site Concentrations of Remifentanil After Intranasal Dexmedetomidine Before Inserting Operative Laryngoscope

    Time frame: 1 day

    Predicted effect-site concentrations of remifentanil after intranasal dexmedetomidine before inserting operative laryngoscope.

    Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator

  49. Predicted Effect-site Concentrations of Remifentanil After Intranasal Placebo on Removal of Operative Laryngoscope

    Time frame: 1 day

    Predicted effect-site concentrations of remifentanil after intranasal placebo on removal of operative laryngoscope.

    Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator

  50. Predicted Effect-site Concentrations of Remifentanil After Intranasal Dexmedetomidine on Removal of Operative Laryngoscope

    Time frame: 1 day

    Predicted effect-site concentrations of remifentanil after intranasal dexmedetomidine on removal of operative laryngoscope.

    Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator

  51. Predicted Effect-site Concentrations of Remifentanil After Intranasal Placebo at Return of Spontaneous Breathing

    Time frame: 1 day

    Predicted effect-site concentrations of remifentanil after intranasal placebo at return of spontaneous breathing.

    Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator

  52. Predicted Effect-site Concentrations of Remifentanil After Intranasal Dexmedetomidine at Return of Spontaneous Breathing

    Time frame: 1 day

    Predicted effect-site concentrations of remifentanil after intranasal dexmedetomidine at return of spontaneous breathing.

    Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator

  53. Predicted Effect-site Concentrations of Remifentanil After Intranasal Placebo at Emergence

    Time frame: 1 day

    Predicted effect-site concentrations of remifentanil after intranasal placebo at emergence.

    Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator

  54. Predicted Effect-site Concentrations of Remifentanil After Intranasal Dexmedetomidine at Emergence

    Time frame: 1 day

    Predicted effect-site concentrations of remifentanil after intranasal dexmedetomidine at emergence.

    Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator

  55. Predicted Effect-site Concentrations of Remifentanil After Intranasal Placebo at Extubation

    Time frame: 1 day

    Predicted effect-site concentrations of remifentanil after intranasal placebo at extubation.

    Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator

  56. Predicted Effect-site Concentrations of Remifentanil After Intranasal Dexmedetomidine at Extubation

    Time frame: 1 day

    Predicted effect-site concentrations of remifentanil after intranasal dexmedetomidine at extubation.

    Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator

  57. HR in the Placebo Group Before Intranasal Drugs

    Time frame: 1 day

    HR in the placebo group Before Intranasal Drugs HR was monitored by fiber-optic pulse oximetry during patient transfer from the ward to the operating room

  58. HR in the Dexmedetomidine Group Before Intranasal Drugs

    Time frame: 1 day

    HR in the dexmedetomidine group Before Intranasal Drugs . HR was monitored by fiber-optic pulse oximetry during patient transfer from the ward to the operating room

  59. HR in the Placebo Group at Pre-induction

    Time frame: 1 day

    HR in the placebo group at pre-induction. HR was monitored by fiber-optic pulse oximetry during patient transfer from the ward to the operating room

  60. HR in the Dexmedetomidine Group at Pre-induction

    Time frame: 1 day

    HR in the dexmedetomidine group at pre-induction. HR was monitored by fiber-optic pulse oximetry during patient transfer from the ward to the operating room

  61. Number of Participants With VAS >50

    Time frame: 1 day

    Patients with postoperative analgesia in two groups. analgesic requests within 2 h after extubation were recorded. An investigator who was blinded from the grouping asked the patients to mark their pain level on a 0-100 visual analogue scale (VAS). A VAS higher than 50 was considered a worse outcome and need to be treated with intravenous 40 mg of parecoxib.

  62. Patients With Postoperative Nausea in Two Groups

    Time frame: 1 day

    Patients With postoperative nausea in Two Groups. Nausea or vomiting was treated with 4 mg of intravenous ondansetron.

  63. Patients With Postoperative Vomiting in Two Groups

    Time frame: 1 day

    Patients With postoperative vomiting in Two Groups. Nausea or vomiting was treated with 4 mg of intravenous ondansetron.

  64. Patients With Postoperative Shivering in Two Groups

    Time frame: 1 day

    Patients With postoperative shivering in Two Groups. the occurrence of postoperative shivering

  65. Patients With Intra-operative Awareness in Two Groups

    Time frame: 1 day

    Patients With intra-operative awareness in Two Groups. patients receiving intranasal placebo or dexmedetomidine

  66. Visual Analogue Scale (VAS) in the Placebo Group

    Time frame: 1 day

    An investigator who was blinded from the grouping asked the patients to mark their pain level on a 0-100 visual analogue scale (VAS). A VAS higher than 50 was considered a worse outcome and need to be treated with intravenous 40 mg of parecoxib.

  67. Visual Analogue Scale (VAS) in the Dexmedetomidine (DEX) Group

    Time frame: 1 day

    An investigator who was blinded from the grouping asked the patients to mark their pain level on a 0-100 visual analogue scale (VAS). A VAS higher than 50 was considered a worse outcome and need to be treated with intravenous 40 mg of parecoxib.

Sponsors and collaborators

Lead sponsor

Guangzhou First People's Hospital

Other

Registry information

Official study title

A Randomised Controlled Trial of Intranasal Dexmedetomidine as Premedication for Suspension Laryngoscopy

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 9, 2014
Registry last updated
Mar 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.