Sedation Effect of Dexmedetomidine Versus Remifentanil to Fibreoptic Intubation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Intubation; Difficult

Intervention / Treatment
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* Drug: dexmedetomidine group
* Drug: remifentanil group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: dexmedetomidine<br>a loading dose (1.5mcg/kg) infused over10 min followed by a continuous infusion of 0.7 μg/kg/h | Drug: dexmedetomidine group<br>* 1-1.5cmg/kg dexmedetomidine infusion within 10 minutes, while followed by maintainly infusing 0.7cmg/kg/min dexmedetomidine<br>* Other names: Dexmedetomidine Hydrochloride Injection;|
| Active Comparator: remifentanil<br>The initial target was 3.0 ng/ml and the TCI was adjusted by 0.5 ng/ml after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was acheived. | Drug: remifentanil group<br>* target controlled 3.5-4ng/ml remifentanil infused(blood plasma concentration)<br>* Other names: Remifentanil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopy Scores | 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 | during the procedure of fibreoptic and tracheal intubation | 
| Intubation Score | 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 | during the inserting of the tracheal tube | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's Reaction to Procedure | 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 | the duration of intubation, an expected average of 10 minutes | 
| Post Operative Visit | 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. | 24 hours | 
| Mean Arterial Blood Pressure | MAP at 15 minutes before intuation, endoscopy point and intubation point between two groups were compared. | 15 minutes before intubation, endoscopy point, intubation point | 
| Heart Rate | Heart rate at 15 minutes before intuation, endoscopy point and intubation point between two groups were compared. | 15 minutes before intubation, endoscopy point, intubation point | 
| Peripheral Oxygen Saturation(SPO2) | Peripheral oxygen saturation at 15 minutes before intuation, endoscopy point and intubation point between two groups were compared. | 15 minutes before intubation, endoscopy point, intubation point | 
| Cardiac Rhythm | 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. | 15 minutes before intubation and duration of intubation | 
| Post Intubation Score | 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） | immediately after the intubation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adult, dexmedetomidine, remifentanil, awake nasotracheal fibreoptic intubation, oral maxillofacial surgery, difficult airway