The Feasibility of Dexmedetomidine for Awake Fiberoptic Nasal Intubation

• ClinicalTrials.gov Identifier: NCT00815893
• Recruitment Status: Unknown
• First Posted: December 31, 2008
• Last Update Posted: July 28, 2009
• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Information provided by: Kaohsiung Medical University Chung-Ho Memorial Hospital

Tracking Information

• First Submitted Date: December 10, 2008
• First Posted Date: December 31, 2008
• Last Update Posted Date: July 28, 2009
• Study Start Date: August 2008
• Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 30, 2008): grading scores presenting conditions for nasal intubation [ Time Frame: before and after intubation ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Feasibility of Dexmedetomidine for Awake Fiberoptic Nasal Intubation
• Official Title: 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: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Awake Fiberoptic Nasal Intubation

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: July 27, 2009): 60
• Original Estimated Enrollment (submitted: December 30, 2008): 30
• Estimated Study Completion Date: August 2009
• Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Taiwan

Administrative Information

• NCT Number: NCT00815893
• Other Study ID Numbers: KMUHIRB-96-09-02
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Koung-Shing Chu, Department of Anesthesiology, Kaohsiung Medical University Chung-Ho Hospital
• Study Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Collaborators: Not Provided

Investigators

• Study Director: Koung-Shing Chu, Master; Kaohsiung Medical University

• PRS Account: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Verification Date: December 2008