The Feasibility of Dexmedetomidine for Awake Fiberoptic Nasal Intubation
NCT ID: NCT00815893
Last Updated: 2009-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
60 participants
INTERVENTIONAL
2008-08-31
2009-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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1 dex group
received dexmedetomidine (1.0 mcg/kg) infusion
dexmedetomidine
dexmedetomidine 1.0 mcg/kg infusion for 10minutes
2 control group
received 0.9% saline
Normal Saline 0.9%
0.9% Normal Saline 0.25ml/kg infusion for 10minues
3 Propofol group
received 1% propofol using effect-site TCI(Base Primea, Fresenius, France)
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.
Interventions
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dexmedetomidine
dexmedetomidine 1.0 mcg/kg infusion for 10minutes
Normal Saline 0.9%
0.9% Normal Saline 0.25ml/kg infusion for 10minues
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Undergoing awake fiberoptic nasal intubation for elective surgery
Exclusion Criteria
* any type of A-V block in EKG
* heart failure
* liver cirrhosis
* thrombocytopenia
* coagulopathy
20 Years
70 Years
ALL
No
Sponsors
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Kaohsiung Medical University Chung-Ho Memorial Hospital
OTHER
Responsible Party
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Department of Anesthesiology, Kaohsiung Medical University Chung-Ho Hospital
Principal Investigators
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Koung-Shing Chu, Master
Role: STUDY_DIRECTOR
Kaohsiung Medical University
Locations
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Kaohsiung Medical University Chung-Ho Hospital
Kaohsiung City, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KMUHIRB-96-09-02
Identifier Type: -
Identifier Source: org_study_id
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