The Feasibility of Dexmedetomidine for Awake Fiberoptic Nasal Intubation

Phase 2

• Conditions: Awake Fiberoptic Nasal Intubation
• Interventions: Drug: propofol 1%; Drug: Normal Saline 0.9%; Drug: dexmedetomidine

• Registration Number: NCT00815893
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief Summary

The objective of this study is to evaluate the feasibility of dexmedetomidine infusion for oral cancer patients undergoing awake fiberoptic nasal intubation. We hypothesized that a loading dose of intravenous dexmedetomidine before awake fiberoptic nasal intubation for oral cancer patients undergoing general anesthesia will provide adequate sedation and analgesia without respiratory depression and upper airway obstruction.

Detailed Description

Case number: 60, ASA I-III oral cancer patients with limited mouth opening

Patients will be randomly allocated into three groups, Dex group received dexmedetomidine (1.0 mcg/kg) infusion, Control group received saline, and Propofol group received 1% Propofol administrated usng effect-site TCI.

Main outcome was evaluated by grading scores presenting conditions for nasal intubation, post-intubation and satisfaction.

Other analysed parameters included airway obstruction, hemodynamic changes, treatment for hemodynamics response, consumption time for intubation, amnesia level, and postoperative adverse events. All outcome measurements were classified by scoring systems.

Study Timeline

• Study Start: 2008-08
• Status Verified: 2008-12
• Study First Submitted: 2008-12-10
• Study First Submitted QC: 2008-12-30
• Study First Posted: 2008-12-31
• Last Update Submitted: 2009-07-27
• Last Update Posted: 2009-07-28
• Primary Completion: 2009-08
• Study Completion: 2009-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Head and neck cancer patients with limited mouth opening
• Undergoing awake fiberoptic nasal intubation for elective surgery

Exclusion Criteria

• a history of severe bradycardia
• any type of A-V block in EKG
• heart failure
• liver cirrhosis
• thrombocytopenia
• coagulopathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
3 Propofol group	propofol 1%	received 1% propofol using effect-site TCI(Base Primea, Fresenius, France)
2 control group	Normal Saline 0.9%	received 0.9% saline
1 dex group	dexmedetomidine	received dexmedetomidine (1.0 mcg/kg) infusion

Primary Outcome Measures

Name	Time	Method
grading scores presenting conditions for nasal intubation	before and after intubation

Trial Locations

Locations (1)

Kaohsiung Medical University Chung-Ho Hospital; 🇨🇳 Kaohsiung, Taiwan