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Completed

NCT Number: NCT01474213

Sedation Effect of Dexmedetomidine Versus Remifentanil to Fibreoptic Intubation

The purpose of this study is to compare the sedation effect of dexmedetomidine and target controlled remifentanil for awake nasotracheal fibreoptic intubation in patients undergoing oral maxillofacial surgery.

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Key information

Conditions

Intubation; Difficult

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shanghai JiaoTong University, School of Medicine, Shanghai, Shanghai Municipality, China

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About this study

Awake fibreoptic nasotracheal intubation is an effective technique for the management of patients with difficult airways undergoing oral maxillofacial surgery. Both optimal intubating conditions and patient comfort are paramount while preparing the patient for fibreoptic intubation. One challenge associated with procedure is to provide adequate sedation while maintaining patients' airway ventilation. Dexmedetomidine, because of its sedative,analgesic properties and minimal influence on patients' ventilation, might be a useful management for it. While with the development of target controlled infusion (TCI) technology, remifentanil sedation becomes a potential sedation in clinical practice.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ASA grade I-III adult patients with difficult airway, who were undergoing elective oral maxillofacial surgery

Exclusion criteria

  • pregnant or lactating female,
  • long-term opioids or sedative medication,
  • patients < 18 years of age,
  • severe bradycardia (HR < 50 beats/min),
  • hypotension (systolic pressure < 90mmHg),
  • any type of atrioventricular block on the ECG

Treatment and study plan

dexmedetomidine group

Drug

1-1.5cmg/kg dexmedetomidine infusion within 10 minutes, while followed by maintainly infusing 0.7cmg/kg/min dexmedetomidine

Other names: Dexmedetomidine Hydrochloride Injection

Remifentanil group

Drug

target controlled 3.5-4ng/ml remifentanil infused(blood plasma concentration)

Other names: Remifentanil

Primary outcomes

  1. Endoscopy Scores

    Time frame: during the procedure of fibreoptic and tracheal intubation

    Endoscopy was graded from 0 to 5, with lower scores indicating a possibly better condition.

    Endoscopy score 0 1 2 3 4 5: 1)Grimacing 2)localising 3)Coughing on lignocaine via scope 4)Coughing on entering infraglottic space 5)Prolonged coughing

  2. Intubation Score

    Time frame: during the inserting of the tracheal tube

    graded from 0 to 5, with lower scores indicating better conditions Intubation score 0 1 2 3 4 5: 1)Grimacing when tube in nares 2)Localising with one limb at any stage 3)Localising with two limbs at any stage 4)Coughing on entering trachea 5)Prolonged coughing

Secondary outcomes

  1. Patient's Reaction to Procedure

    Time frame: the duration of intubation, an expected average of 10 minutes

    Ramsay score during the endoscopy intubation from 1 to 6. The higher scores means the deeper sedation level.

    Clinical score Level of sedation

    • Patient is anxious and agitated or restless, or both
    • Patient is cooperative, oriented and tranquil
    • Patient responds to commands only
    • Patient exhibits a brisk response to a light glabellar (between the eyebrows) tap or loud auditory stimulus
    • Patient exhibits a sluggish response to a light glabellar tap or loud auditory stimulus
    • Patient exhibits no response to stimuli

  2. Post Operative Visit

    Time frame: 24 hours

    visit the patients to ensure their memory of intubation. Postoperative interview asked the patients' memory of the fiberoptic intubation Amnesia Recall of endoscopy Yes No Recall of intubation Yes No The number is the patients who remember the operation procedure.

  3. Mean Arterial Blood Pressure

    Time frame: 15 minutes before intubation, endoscopy point, intubation point

    MAP at 15 minutes before intuation, endoscopy point and intubation point between two groups were compared.

  4. Heart Rate

    Time frame: 15 minutes before intubation, endoscopy point, intubation point

    Heart rate at 15 minutes before intuation, endoscopy point and intubation point between two groups were compared.

  5. Peripheral Oxygen Saturation(SPO2)

    Time frame: 15 minutes before intubation, endoscopy point, intubation point

    Peripheral oxygen saturation at 15 minutes before intuation, endoscopy point and intubation point between two groups were compared.

  6. Cardiac Rhythm

    Time frame: 15 minutes before intubation and duration of intubation

    Number of Participants with Abnormal Cardiac Rhythm(including any type of the abnormal cardiac rhythm from 15 minutes before intubation and during the intubation procedure was recorded such as sinus arrhythm, atrial or ventricular premature beats and atrioventricular block) was recorded.

  7. Post Intubation Score

    Time frame: immediately after the intubation

    Post-intubation was scored from 1 to 3, with higher scores indicating a worse outcome.

    Post-intubation score 1 2 3

    • Cooperative, obeying commands
    • Uncomfortable, GA imminent
    • Other（specify）

Sponsors and collaborators

Lead sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Other

Registry information

Official study title

Dexmedetomidine Versus Remifentanil Target Controlled Infusion for Sedation During Awake Fibreoptic Nasotracheal Intubation

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 18, 2011
Registry last updated
Nov 21, 2012

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

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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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