Sedation Effect of Dexmedetomidine Versus Remifentanil to Fibreoptic Intubation

Phase 4

Completed

• Conditions: Intubation; Difficult
• Interventions: Drug: dexmedetomidine group; Drug: remifentanil group

• Registration Number: NCT01474213
• Lead Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2011-10-31
• Study Start: 2011-11
• Study First Submitted QC: 2011-11-15
• Study First Posted: 2011-11-18
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Results First Submitted: 2012-06-06
• Status Verified: 2012-10
• Results First Submitted QC: 2012-10-22
• Last Update Submitted: 2012-10-22
• Results First Posted: 2012-11-21
• Last Update Posted: 2012-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dexmedetomidine	dexmedetomidine group	a loading dose (1.5mcg/kg) infused over10 min followed by a continuous infusion of 0.7 μg/kg/h
remifentanil	remifentanil group	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.

Primary Outcome Measures

Name	Time	Method
Endoscopy Scores	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
Intubation Score	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 Outcome Measures

Name	Time	Method
Patient's Reaction to Procedure	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; 1. Patient is anxious and agitated or restless, or both; 2. Patient is cooperative, oriented and tranquil; 3. Patient responds to commands only; 4. Patient exhibits a brisk response to a light glabellar (between the eyebrows) tap or loud auditory stimulus; 5. Patient exhibits a sluggish response to a light glabellar tap or loud auditory stimulus; 6. Patient exhibits no response to stimuli
Post Operative Visit	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.
Mean Arterial Blood Pressure	15 minutes before intubation, endoscopy point, intubation point	MAP at 15 minutes before intuation, endoscopy point and intubation point between two groups were compared.
Heart Rate	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.
Peripheral Oxygen Saturation(SPO2)	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.
Cardiac Rhythm	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.
Post Intubation Score	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; 1. Cooperative, obeying commands; 2. Uncomfortable, GA imminent; 3. Other（specify）

Trial Locations

Locations (2)

Shanghai JiaoTong University, School of Medicine; 🇨🇳 Shanghai, Shanghai, China

Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University, School of Medicine; 🇨🇳 Shanghai, Shanghai, China