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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

December 10, 2008
July 27, 2009
August 2008
August 2009   (final data collection date for primary outcome measure)
grading scores presenting conditions for nasal intubation [ Time Frame: before and after intubation ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00815893 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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The Feasibility of Dexmedetomidine for Awake Fiberoptic Nasal Intubation
Interventional Study of Dexmedetomidine for Sedating Anticipated Difficult Airway Patients Undergoing Awake Fiberoptic Nasal Intubation

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Awake Fiberoptic Nasal Intubation
  • 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
  • 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%
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
August 2009
August 2009   (final data collection date for primary outcome measure)

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
Both
20 Years to 70 Years
No
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
Taiwan
 
NCT00815893
KMUHIRB-96-09-02
Yes
Koung-Shing Chu, Department of Anesthesiology, Kaohsiung Medical University Chung-Ho Hospital
Kaohsiung Medical University Chung-Ho Memorial Hospital
Not Provided
Study Director: Koung-Shing Chu, Master Kaohsiung Medical University
Kaohsiung Medical University Chung-Ho Memorial Hospital
December 2008

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