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


Phase 2/Phase 3
20 Years
70 Years
Open (Enrolling)
Both
Awake Fiberoptic Nasal Intubation

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Trial Information

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


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.


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

Type of Study:

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

Outcome Measure:

grading scores presenting conditions for nasal intubation

Outcome Time Frame:

before and after intubation

Safety Issue:

Yes

Principal Investigator

Koung-Shing Chu, Master

Investigator Role:

Study Director

Investigator Affiliation:

Kaohsiung Medical University

Authority:

Taiwan: Institutional Review Board

Study ID:

KMUHIRB-96-09-02

NCT ID:

NCT00815893

Start Date:

August 2008

Completion Date:

August 2009

Related Keywords:

  • Awake Fiberoptic Nasal Intubation
  • Dexmedetomidine
  • Fiberoptic nasal intubation
  • satisfaction

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