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The Feasibility of Dexmedetomidine for Awake Fiberoptic Nasal Intubation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00815893
Recruitment Status : Unknown
Verified December 2008 by Kaohsiung Medical University Chung-Ho Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : December 31, 2008
Last Update Posted : July 28, 2009
Sponsor:
Information provided by:
Kaohsiung Medical University Chung-Ho Memorial Hospital

Tracking Information
First Submitted Date  ICMJE December 10, 2008
First Posted Date  ICMJE December 31, 2008
Last Update Posted Date July 28, 2009
Study Start Date  ICMJE August 2008
Estimated Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 30, 2008)
grading scores presenting conditions for nasal intubation [ Time Frame: before and after intubation ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, 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 Arms  ICMJE
  • 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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 27, 2009)
60
Original Estimated Enrollment  ICMJE
 (submitted: December 30, 2008)
30
Estimated Study Completion Date  ICMJE 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00815893
Other Study ID Numbers  ICMJE KMUHIRB-96-09-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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
PRS Account 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