Sedation Effect of Dexmedetomidine Versus Remifentanil to Fibreoptic Intubation

Condition(s) targeted: Intubation; Difficult

Intervention: dexmedetomidine group (Drug); remifentanil group (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Shanghai 9th People's Hospital

Official(s) and/or principal investigator(s):
Hong Jiang, MD, PHD, Study Chair, Affiliation: Anesthesiology Department, Shanghai Ninth People's Hospital Affiliated Shanghai JiaoTong University School of Medicine

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Primary outcome:

Endoscopy Scores

Intubation Score

Secondary outcome:

Patient's Reaction to Procedure

Post Operative Visit

Mean Arterial Blood Pressure

Heart Rate

Peripheral Oxygen Saturation(SPO2)

Cardiac Rhythm

Post Intubation Score

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Shanghai JiaoTong University, School of Medicine, Shanghai, Shanghai 200011, China

Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University, School of Medicine, Shanghai, Shanghai 200011, China

Starting date: November 2011
Last updated: October 22, 2012