The Feasibility of Dexmedetomidine for Awake Fiberoptic Nasal Intubation
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|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
|Condition or disease||Intervention/treatment||Phase|
|Awake Fiberoptic Nasal Intubation||Drug: dexmedetomidine Drug: Normal Saline 0.9% Drug: propofol 1%||Phase 2 Phase 3|
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 (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Experimental: 1 dex group
received dexmedetomidine (1.0 mcg/kg) infusion
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
- grading scores presenting conditions for nasal intubation [ Time Frame: before and after intubation ]
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
|Contact: Koung-Shing Chu, Master||886-7-3121101 ext firstname.lastname@example.org|
|Contact: Cheng-Jing Tsai||886-7-3121131 ext email@example.com|
|Kaohsiung Medical University Chung-Ho Hospital||Recruiting|
|Kaohsiung, Taiwan, 807|
|Contact: Koung-Shing Chu, Master 886-7-3121101 ext 7035 firstname.lastname@example.org|
|Study Director:||Koung-Shing Chu, Master||Kaohsiung Medical University|