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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Awake Fiberoptic Nasal Intubation
 Drug: dexmedetomidine
Drug: Normal Saline 0.9%
Drug: propofol 1%
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Interventional Study of Dexmedetomidine for Sedating Anticipated Difficult Airway Patients Undergoing Awake Fiberoptic Nasal Intubation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:

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

Estimated Enrollment: 60
Study Start Date: August 2008
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 dex group
received dexmedetomidine (1.0 mcg/kg) infusion
 Drug: dexmedetomidine
dexmedetomidine 1.0 mcg/kg infusion for 10minutes
Other Name: Precedex 100microg/ml
Placebo Comparator: 2 control group
received 0.9% saline
 Drug: Normal Saline 0.9%
0.9% Normal Saline 0.25ml/kg infusion for 10minues
Other Name: saline 0.9% Nacl
Active Comparator: 3 Propofol group
received 1% propofol using effect-site TCI(Base Primea, Fresenius, France)
 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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00815893

Contacts
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

Locations
Taiwan
Kaohsiung Medical University Chung-Ho Hospital Recruiting
Kaohsiung, Taiwan, 807
Contact: Koung-Shing Chu, Master     886-7-3121101 ext 7035     cks0708@ms.kmuh.org.tw    
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
Investigators
Study Director: Koung-Shing Chu, Master Kaohsiung Medical University
  More Information

No publications provided

Responsible Party: Koung-Shing Chu, Department of Anesthesiology, Kaohsiung Medical University Chung-Ho Hospital
ClinicalTrials.gov Identifier: NCT00815893     History of Changes
Other Study ID Numbers: KMUHIRB-96-09-02
Study First Received: December 10, 2008
Last Updated: July 27, 2009
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:
Dexmedetomidine
Fiberoptic nasal intubation
satisfaction

Additional relevant MeSH terms:
Propofol
Dexmedetomidine
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013