Clinical trial NCT01474213: Sedation Effect of Dexmedetomidine Versus Remifentanil to Fibreoptic Intubation
Official title: Dexmedetomidine Versus Remifentanil Target Controlled Infusion for Sedation During Awake Fibreoptic Nasotracheal Intubation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intubation; Difficult
Keywords: dexmedetomidine
remifentanil
awake nasotracheal fibreoptic intubation
oral maxillofacial surgery
difficult airway
adult
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2011-11-18
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Endoscopy Scores
timeFrame: during the procedure of fibreoptic and tracheal intubation
measure: Intubation Score
timeFrame: during the inserting of the tracheal tube
Secondary outcomes:
measure: Patient's Reaction to Procedure
timeFrame: the duration of intubation, an expected average of 10 minutes
measure: Post Operative Visit
timeFrame: 24 hours
measure: Mean Arterial Blood Pressure
timeFrame: 15 minutes before intubation, endoscopy point, intubation point
measure: Heart Rate
timeFrame: 15 minutes before intubation, endoscopy point, intubation point
measure: Peripheral Oxygen Saturation(SPO2)
timeFrame: 15 minutes before intubation, endoscopy point, intubation point
measure: Cardiac Rhythm
timeFrame: 15 minutes before intubation and duration of intubation
measure: Post Intubation Score
timeFrame: immediately after the intubation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai JiaoTong University, School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University, School of Medicine
state: Shanghai
Study officials:
affiliation: Anesthesiology Department, Shanghai Ninth People's Hospital Affiliated Shanghai JiaoTong University School of Medicine
name: Hong Jiang, MD, PHD
role: STUDY_CHAIR
References: