The Feasibility of Dexmedetomidine for Awake Fiberoptic Nasal Intubation

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2008 by Kaohsiung Medical University Chung-Ho Memorial Hospital.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Kaohsiung Medical University Chung-Ho Memorial Hospital

ClinicalTrials.gov Identifier:

NCT00815893

First received: December 10, 2008

Last updated: July 27, 2009

Last verified: December 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

December 10, 2008

Last Updated Date

July 27, 2009

Start Date ^ICMJE

August 2008

Estimated Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

grading scores presenting conditions for nasal intubation [ Time Frame: before and after intubation ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00815893 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

The Feasibility of Dexmedetomidine for Awake Fiberoptic Nasal Intubation

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Awake Fiberoptic Nasal Intubation

Intervention ^ICMJE

Drug: dexmedetomidine
dexmedetomidine 1.0 mcg/kg infusion for 10minutes

Other Name: Precedex 100microg/ml
Drug: Normal Saline 0.9%
0.9% Normal Saline 0.25ml/kg infusion for 10minues

Other Name: saline 0.9% Nacl
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.

Other Name: propofol

Study Arm (s)

Experimental: 1 dex group
received dexmedetomidine (1.0 mcg/kg) infusion

Intervention: Drug: dexmedetomidine
Placebo Comparator: 2 control group
received 0.9% saline

Intervention: Drug: Normal Saline 0.9%
Active Comparator: 3 Propofol group
received 1% propofol using effect-site TCI(Base Primea, Fresenius, France)

Intervention: Drug: propofol 1%

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

August 2009

Estimated Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Koung-Shing Chu, Master	886-7-3121101 ext 7035	cks0708@ms.kmuh.org.tw
Contact: Cheng-Jing Tsai	886-7-3121131 ext 7033	t8501107@yahoo.com.tw

Location Countries ^ICMJE

Taiwan

Administrative Information

NCT Number ^ICMJE

NCT00815893

Other Study ID Numbers ^ICMJE

KMUHIRB-96-09-02

Has Data Monitoring Committee

Yes

Responsible Party

Koung-Shing Chu, Department of Anesthesiology, Kaohsiung Medical University Chung-Ho Hospital

Study Sponsor ^ICMJE

Kaohsiung Medical University Chung-Ho Memorial Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Koung-Shing Chu, Master

Kaohsiung Medical University

Information Provided By

Kaohsiung Medical University Chung-Ho Memorial Hospital

Verification Date

December 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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