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Anesthetic Advantages of Dexmedetomidine for Hypotensive Anesthesia

Information source: Mahidol University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anesthesia; Hypotension

Intervention: Dexmedetomidine (Drug); Nitroglycerin (Drug)

Phase: N/A

Status: Completed

Sponsored by: Mahidol University

Official(s) and/or principal investigator(s):
Duangdee Rummasak, M.D., Principal Investigator, Affiliation: faculty of dentistry, Mahidol university


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: amount of intraoperative fentanyl

Secondary outcome:

time to eye opening

time to follow verbal command

time to extubation

postoperative pain score at 30 minute

postoperative pain score at 60 minute

amount of pethidine

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.


Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.


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

Locations and Contacts

Faculty of dentistry, Mahidol university, Rajthevi, Bangkok 10400, Thailand
Additional Information

Related publications:

Apipan B, Rummasak D. Efficacy and safety of oral propranolol premedication to reduce reflex tachycardia during hypotensive anesthesia with sodium nitroprusside in orthognathic surgery: a double-blind randomized clinical trial. J Oral Maxillofac Surg. 2010 Jan;68(1):120-4. doi: 10.1016/j.joms.2009.07.065.

Rummasak D, Apipan B, Kaewpradup P. Factors that determine intraoperative blood loss in bimaxillary osteotomies and the need for preoperative blood preparation. J Oral Maxillofac Surg. 2011 Nov;69(11):e456-60. doi: 10.1016/j.joms.2011.02.085. Epub 2011 Jul 2.

Piñeiro-Aguilar A, Somoza-Martín M, Gandara-Rey JM, García-García A. Blood loss in orthognathic surgery: a systematic review. J Oral Maxillofac Surg. 2011 Mar;69(3):885-92. doi: 10.1016/j.joms.2010.07.019. Epub 2010 Dec 31. Review.

Choi WS, Samman N. Risks and benefits of deliberate hypotension in anaesthesia: a systematic review. Int J Oral Maxillofac Surg. 2008 Aug;37(8):687-703. doi: 10.1016/j.ijom.2008.03.011. Epub 2008 Jun 3. Review.

Praveen K, Narayanan V, Muthusekhar MR, Baig MF. Hypotensive anaesthesia and blood loss in orthognathic surgery: a clinical study. Br J Oral Maxillofac Surg. 2001 Apr;39(2):138-40.

El-Gohary MM, Arafa AS. Dexmedetomidine as ahypotensive agent: efficacy and hemodynamic response during spinal surgery for idiopathic scoliosis in adolescents. Egyptain Journal of Aanesthesia 2010; 26: 305-11.

Starting date: December 2012
Last updated: March 6, 2014

Page last updated: August 23, 2015

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