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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
Sponsor:
Information provided by (Responsible Party):
Duangdee Rummasak, 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.

Condition or disease Intervention/treatment Phase
Anesthesia Hypotension Drug: Dexmedetomidine Drug: Nitroglycerin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: dexmedetomidine
Intraoperative controlled hypotension by dexmedetomidine
Drug: 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
Drug: 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




Primary Outcome Measures :
  1. amount of intraoperative fentanyl [ Time Frame: intraoperatve period ]
    Record the amount of fentanyl used in the operation.


Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Thailand
Faculty of dentistry, Mahidol university
Rajthevi, Bangkok, Thailand, 10400
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Duangdee Rummasak, M.D. faculty of dentistry, Mahidol university
Publications:
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Responsible Party: Duangdee Rummasak, department of oral and maxillofacial surgery, faculty of dentistry, Mahidol University
ClinicalTrials.gov Identifier: NCT02083055    
Other Study ID Numbers: MU-DT/PY-IRB 2012/021.1904
First Posted: March 11, 2014    Key Record Dates
Last Update Posted: March 11, 2014
Last Verified: March 2014
Keywords provided by Duangdee Rummasak, Mahidol University:
dexmedetomidine
controlled hypotensive anesthesia
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases
Nitroglycerin
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents