Anesthetic Advantages of Dexmedetomidine for Hypotensive Anesthesia

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anesthesia, Hypotension

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Nitroglycerin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dexmedetomidine<br>Intraoperative controlled hypotension by dexmedetomidine | Drug: Dexmedetomidine<br>* 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<br>* Other names: precedex;|
| Active Comparator: nitroglycerin<br>Intraoperative controlled hypotension by nitroglycerin | Drug: Nitroglycerin<br>* 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.<br>* Other names: nitrocine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amount of intraoperative fentanyl | Record the amount of fentanyl used in the operation. | intraoperatve period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to eye opening | the time that counted from closed anesthetic drugs and reversed muscle relaxant to patients eye opening. | emergence of anesthesia | 
| time to follow verbal command | 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. | emergence of anesthesia | 
| time to extubation | the time that counted from closed anesthetic drugs and reversed muscle relaxant to remove the nasotracheal tube. | emergence of anesthesia | 
| postoperative pain score at 30 minute | postoperative pain score at 30 minute using 10-point pain assessment scale. | early postoperative period | 
| postoperative pain score at 60 minute | postoperative pain score at 60 minute using 10-point pain assessment scale. | early postoperative period | 
| amount of pethidine | Record the amount of pethidine that used for a pain killer when pain score more than 4 in first 2 hours post-operation. | early postoperative period (first 2 hours) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dexmedetomidine, controlled hypotensive anesthesia