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