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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

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Interventional Study of Dexmedetomidine for Sedating Anticipated Difficult Airway Patients Undergoing Awake Fiberoptic Nasal Intubation
Study Start Date : August 2008
Estimated Primary Completion Date : August 2009
Estimated Study Completion Date : August 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. grading scores presenting conditions for nasal intubation [ Time Frame: before and after intubation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00815893


Contacts
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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
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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
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Study Director: Koung-Shing Chu, Master Kaohsiung Medical University
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Responsible Party: Koung-Shing Chu, Department of Anesthesiology, Kaohsiung Medical University Chung-Ho Hospital
ClinicalTrials.gov Identifier: NCT00815893    
Other Study ID Numbers: KMUHIRB-96-09-02
First Posted: December 31, 2008    Key Record Dates
Last Update Posted: July 28, 2009
Last Verified: December 2008
Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:
Dexmedetomidine
Fiberoptic nasal intubation
satisfaction
Additional relevant MeSH terms:
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Dexmedetomidine
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
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