Clinical trial NCT02083055: Anesthetic Advantages of Dexmedetomidine for Hypotensive Anesthesia
Official title: Anesthetic Advantages of Dexmedetomidine Compared With Nitroglycerin for Hypotensive Anesthesia in Orthognathic Surgery. A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Hypotension
Keywords: dexmedetomidine
controlled hypotensive anesthesia
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2014-03-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: amount of intraoperative fentanyl
timeFrame: intraoperatve period
Secondary outcomes:
measure: time to eye opening
timeFrame: emergence of anesthesia
measure: time to follow verbal command
timeFrame: emergence of anesthesia
measure: time to extubation
timeFrame: emergence of anesthesia
measure: postoperative pain score at 30 minute
timeFrame: early postoperative period
measure: postoperative pain score at 60 minute
timeFrame: early postoperative period
measure: amount of pethidine
timeFrame: early postoperative period (first 2 hours)
Other outcomes:
Locations:
city: Rajthevi
country: Thailand
facility: Faculty of dentistry, Mahidol university
state: Bangkok
Study officials:
affiliation: faculty of dentistry, Mahidol university
name: Duangdee Rummasak, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Pineiro-Aguilar A, Somoza-Martin M, Gandara-Rey JM, Garcia-Garcia 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.
citation: 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.
citation: 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. doi: 10.1054/bjom.2000.0593.
citation: 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.