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Completed

NCT Number: NCT04753515

Dexmedetomidine Versus Propofol for Sedation During Awake Endotracheal Intubation

The purpose of this study is to compare the sedation effect of dexmedetomidine and propofol when they are both combined with midazolam and remifentanil during awake endotracheal intubation.

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Key information

Conditions

Sedation Intubation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

the Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

About this study

Awake intubation is one of the best strategy guaranteed by the American Society of Anesthesiologists (ASA) guidelines for the management of patients with anticipated difficult airways. Hemodynamic stability, optimal intubating conditions, patients' comfort, amnesia and preservation of patents' spontaneous respiration are critical for awake intubation. Sedation is one of the key elements for this technique. Intravenous midazolam, propofol, dexmedetomidine and remifentanil are commonly used as sedatives during awake intubation. These agents are not preferred to be used alone but in combination with each other for the purpose of minimizing their respective side effects. The aim of this randomized controlled trial is to compare the safety and effectiveness of dexmedetomidine versus propofol for sedation during awake endotracheal intubation when they are both combined with midazolam and remifentanil.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18-65 Years old;
  • scheduled for elective surgery under general anesthesia with oral tracheal intubation;
  • The American Society of Anesthesiologists(ASA) grade is I or II, and the cardiac function is 1-2;
  • Body mass index (BMI) 18-30 kg/m2.

Exclusion criteria

  • Patients have severe cardiac diseases (cardiac function grading greater than grade 3/arrhythmia including sick sinus syndrome, atrial fibrillation, atrial flutter, atrioventricular block, frequent ventricular premature, multiple ventricular premature, ventricular premature R on T, ventricular fibrillation and ventricular flutter/acute coronary syndrome) or respiratory failure or hepatic failure or renal failure;
  • body mass index (BMI) ≥30 kg/m2 or <18 kg/m2;
  • Patients with poor blood pressure control (receive regular antihypertensive medical treatment but still have systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 90 mmHg);
  • Patients with a higher risk of reflux and aspiration, such as full stomach, gastrointestinal obstruction, gastroparesis, and pregnant women;
  • Patients have schizophrenia, epilepsy, Parkinson's disease, intellectual disability, hearing impairment.;
  • Patients who take sedative and analgesic drugs for a long time;
  • Patients who are allergic to propofol, dexmedetomidine, midazolam or remifentanil
  • Patients who are expected to be difficult to intubate;
  • Patients who are participating in other clinical trials, or who refuse to sign informed consent.

Treatment and study plan

dexmedetomidine combined with midazolam and remifentanil.

Drug

Patients in this group will receive a bolus of midazolam 0.03 mg/kg intravenously, and then a loading dose of 0.5 mcg/kg remifentanil and 0.5 mcg/kg dexmedetomidine over 5 min via separate syringe pumps.

Other names: dexmedetomidine-midazolam-remifentanil

propofol combined with midazolam and remifentanil.

Drug

Patients in this group will receive a bolus of midazolam 0.03 mg/kg intravenously, and then a loading dose of 0.5 mcg/kg remifentanil and 0.33 mg/kg propoful over 5 min via separate syringe pumps.

Other names: propofol-midazolam-remifentanil

Primary outcomes

  1. blood pressure

    Time frame: During the procedure of general anesthesia induction, expected an average of 20 min

    systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean blood pressure (MBP) shown in the monitor.

Secondary outcomes

  1. intubation condition score

    Time frame: During the procedure of general anesthesia induction, expected an average of 20 min

    Assessment of the intubation condition according to the scale of the modified Erhan's intubation condition score which includes jaw relaxation, laryngoscopy, vocal cord position, and patient's response (coughing, limb movement) to intubation and inflation of the intubation tube cuff.

Other outcomes

  1. degree of coughing

    Time frame: During the procedure of general anesthesia induction, expected an average of 20 min.

    Grade assessment of coughing during the peri-intubation period (1 = No cough and limb activity, 2 = Intermittent cough with slight activity of chest and abdomen, 3 = Continuous cough with large amplitude activity of chest and abdomen, no limb activity, 4 = Continuous cough with large amplitude activity of chest and abdomen and limbs)

  2. heart rate

    Time frame: During the procedure of general anesthesia induction, expected an average of 20 min.

    Heart rate shown in the monitor

  3. pulse oxygen saturation (SpO2)

    Time frame: During the procedure of general anesthesia induction, expected an average of 20 min.

    SpO2 shown in the monitor

  4. level of recall

    Time frame: postoperative follow-up visit 24 hours after the operation, expected an average of 5 min.

    At the 24-h postoperative follow-up visit, patients will be interviewed to assess their recall of pre-anesthesia events, administration of topical anesthesia, endoscopy and intubation.

  5. satisfaction score

    Time frame: postoperative follow-up visit 24 hours after the operation, expected an average of 5 min.

    At the 24-h postoperative follow-up visit, patients will be interviewed to assess their satisfaction about the procedure of awake intubation (1 = excellent, 2 = good, 3 = fair, 4 = poor).

  6. adverse events

    Time frame: postoperative follow-up visit 24 hours after the operation, expected an average of 5 min.

    At the 24-h postoperative follow-up visit, patients will be interviewed to assess the adverse events related to endotracheal intubation (postoperative hoarseness or sore throat)

Sponsors and collaborators

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Other

Registry information

Official study title

Comparison Between Dexmedetomidine and Propofol for Sedation When Combined With Midazolam and Remifentanil During Awake Endotracheal Intubation: A Randomized Double-blind Controlled Study

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 15, 2021
Registry last updated
Nov 30, 2022

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.

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