Anesthetic Advantages of Dexmedetomidine for Hypotensive Anesthesia
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|ClinicalTrials.gov Identifier: NCT02083055|
Recruitment Status : Completed
First Posted : March 11, 2014
Last Update Posted : March 11, 2014
|Condition or disease||Intervention/treatment||Phase|
|Anesthesia Hypotension||Drug: Dexmedetomidine Drug: Nitroglycerin||Not Applicable|
The subject included the healthy patients who underwent orthognathic surgery and gave written the informed consent. The sample size was calculate from the amount of fentanyl use in orthognathic surgical case and difference more 30% was significant. Randomization was done by random number table to 2 groups. Both groups received standardized controlled hypotensive anesthesia and surgery. D group used dexmedetomidine as the hypotensive drug and N group use nitroglycerin. The main outcome were the amount of fentanyl use, time to eye opening, follow simple command, extubation, early postoperative pain, and early postoperative amount of pain killer. All recorded by anesthesiologist on data sheet.
compare statistical analysis used compare mean by unpaired student t test.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Anesthetic Advantages of Dexmedetomidine Compared With Nitroglycerin for Hypotensive Anesthesia in Orthognathic Surgery. A Randomized Clinical Trial.|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2014|
Intraoperative controlled hypotension by dexmedetomidine
controlled hypotensive anesthesia with dexmedetomidine compare with nitroglycerin on anesthetic outcome such as analgesic use, time to eye opening, follow verbal command, extubation and early postoperative pain
Other Name: precedex
Active Comparator: nitroglycerin
Intraoperative controlled hypotension by nitroglycerin
controlled hypotensive anesthesia with nitroglycerin compared with dexmedetomidine on anesthetic outcomes such as analgesic use, time to eye opening, follow verbal command, extubation, and early postoperative pain.
Other Name: nitrocine
- amount of intraoperative fentanyl [ Time Frame: intraoperatve period ]Record the amount of fentanyl used in the operation.
- time to eye opening [ Time Frame: emergence of anesthesia ]the time that counted from closed anesthetic drugs and reversed muscle relaxant to patients eye opening.
- time to follow verbal command [ Time Frame: emergence of anesthesia ]the time that counted from closed anesthetic drugs and reversed muscle relaxant to patients can follow simple verbal command such as open mouth, protrude the tongue, move the hand.
- time to extubation [ Time Frame: emergence of anesthesia ]the time that counted from closed anesthetic drugs and reversed muscle relaxant to remove the nasotracheal tube.
- postoperative pain score at 30 minute [ Time Frame: early postoperative period ]postoperative pain score at 30 minute using 10-point pain assessment scale.
- postoperative pain score at 60 minute [ Time Frame: early postoperative period ]postoperative pain score at 60 minute using 10-point pain assessment scale.
- amount of pethidine [ Time Frame: early postoperative period (first 2 hours) ]Record the amount of pethidine that used for a pain killer when pain score more than 4 in first 2 hours post-operation.
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): NCT02083055
|Faculty of dentistry, Mahidol university|
|Rajthevi, Bangkok, Thailand, 10400|
|Principal Investigator:||Duangdee Rummasak, M.D.||faculty of dentistry, Mahidol university|