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Clinical Trials/NCT02083055
NCT02083055
Completed
Not Applicable

Anesthetic Advantages of Dexmedetomidine Compared With Nitroglycerin for Hypotensive Anesthesia in Orthognathic Surgery. A Randomized Clinical Trial.

Mahidol University1 site in 1 country40 target enrollmentDecember 2012

Overview

Phase
Not Applicable
Intervention
Dexmedetomidine
Conditions
Anesthesia
Sponsor
Mahidol University
Enrollment
40
Locations
1
Primary Endpoint
amount of intraoperative fentanyl
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2012
End Date
February 2014
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Duangdee Rummasak

department of oral and maxillofacial surgery, faculty of dentistry

Mahidol University

Eligibility Criteria

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

Arms & Interventions

dexmedetomidine

Intraoperative controlled hypotension by dexmedetomidine

Intervention: Dexmedetomidine

nitroglycerin

Intraoperative controlled hypotension by nitroglycerin

Intervention: Nitroglycerin

Outcomes

Primary Outcomes

amount of intraoperative fentanyl

Time Frame: intraoperatve period

Record the amount of fentanyl used in the operation.

Secondary Outcomes

  • time to eye opening(emergence of anesthesia)
  • time to follow verbal command(emergence of anesthesia)
  • time to extubation(emergence of anesthesia)
  • postoperative pain score at 30 minute(early postoperative period)
  • postoperative pain score at 60 minute(early postoperative period)
  • amount of pethidine(early postoperative period (first 2 hours))

Study Sites (1)

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