NCT00815893

The Feasibility of Dexmedetomidine for Awake Fiberoptic Nasal Intubation

Interventional Study of Dexmedetomidine for Sedating Anticipated Difficult Airway Patients Undergoing Awake Fiberoptic Nasal Intubation

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Awake Fiberoptic Nasal Intubation

Interventions

Type	Name	Description
DRUG	dexmedetomidine	dexmedetomidine 1.0 mcg/kg infusion for 10minutes
DRUG	Normal Saline 0.9%	0.9% Normal Saline 0.25ml/kg infusion for 10minues
DRUG	propofol 1%	Propofol: The initial target = 3 μg/ml. The TCI is adjusted by 0.5μg/ml according to patient comfort during the procedure. The Orchestra® Base Primea(Fresenius, Brezins, France) offers a Target Controlled Infusion (TCI) target controlled infusion.

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2008-12-31
• Last updated: 2009-07-28

Locations

1 site across 1 country: Taiwan