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Completed

NCT Number: NCT02083055

Anesthetic Advantages of Dexmedetomidine for Hypotensive Anesthesia

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.

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Key information

Conditions

Anesthesia Cardiovascular Diseases Hypotension Vascular Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of dentistry, Mahidol university

Rajthevi, Bangkok, 10400, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

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 names: precedex

Nitroglycerin

Drug

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 names: nitrocine

Primary outcomes

  1. amount of intraoperative fentanyl

    Time frame: intraoperatve period

    Record the amount of fentanyl used in the operation.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. postoperative pain score at 30 minute

    Time frame: early postoperative period

    postoperative pain score at 30 minute using 10-point pain assessment scale.

  5. postoperative pain score at 60 minute

    Time frame: early postoperative period

    postoperative pain score at 60 minute using 10-point pain assessment scale.

  6. 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.

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 11, 2014
Registry last updated
Mar 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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