Anesthetic Advantages of Dexmedetomidine for Hypotensive Anesthesia

Not Applicable

Completed

• Conditions: Anesthesia; Hypotension
• Interventions: Drug: Dexmedetomidine; Drug: Nitroglycerin

• Registration Number: NCT02083055
• Lead Sponsor: Mahidol University

Brief Summary

The aim of this study was to evaluate the positive anesthetic properties such as reduce intraoperative analgesic requirement, time to extubation and recovery, and early postoperative pain of dexmedetomidine used as a hypotensive agent compared with nitroglycerin.

Detailed Description

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 Timeline

• Study Start: 2012-12
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2014-03
• Study First Submitted: 2014-03-06
• Study First Submitted QC: 2014-03-06
• Last Update Submitted: 2014-03-06
• Study First Posted: 2014-03-11
• Last Update Posted: 2014-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• patients who undergo bimaxillary surgery physical status I according to the classification of the American Society of Anesthesiologist age 18-45 years

Exclusion Criteria

• systemic diseases not given informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dexmedetomidine	Dexmedetomidine	Intraoperative controlled hypotension by dexmedetomidine
nitroglycerin	Nitroglycerin	Intraoperative controlled hypotension by nitroglycerin

Primary Outcome Measures

Name	Time	Method
amount of intraoperative fentanyl	intraoperatve period	Record the amount of fentanyl used in the operation.

Secondary Outcome Measures

Name	Time	Method
time to eye opening	emergence of anesthesia	the time that counted from closed anesthetic drugs and reversed muscle relaxant to patients eye opening.
time to follow verbal command	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	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	early postoperative period	postoperative pain score at 30 minute using 10-point pain assessment scale.
postoperative pain score at 60 minute	early postoperative period	postoperative pain score at 60 minute using 10-point pain assessment scale.
amount of pethidine	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.

Trial Locations

Locations (1)

Faculty of dentistry, Mahidol university; 🇹🇭 Rajthevi, Bangkok, Thailand