Sedation Effect of Dexmedetomidine Versus Remifentanil to Fibreoptic Intubation

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University42 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Intubation; Difficult

Interventions

dexmedetomidine groupDRUG

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

remifentanil groupDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Shanghai JiaoTong University, School of Medicine

Shanghai, Shanghai Municipality, China

Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University, School of Medicine

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: during the inserting of the tracheal tube

Secondary Outcomes

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 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

Time frame: 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.

Time frame: 24 hours

Mean Arterial Blood Pressure

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

Data from ClinicalTrials.gov

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