Anesthetic Advantages of Dexmedetomidine for Hypotensive Anesthesia

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02083055
• Other study ID #: MU-DT/PY-IRB 2012/021.1904
• Status: Completed
• Phase: N/A
• First received: March 6, 2014
• Last updated: March 6, 2014
• Start date: December 2012
• Est. completion date: February 2014

Study information

• Verified date: March 2014
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Anesthesia
• Hypotension

Intervention

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
• 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.

Locations

Country	Name	City	State
Thailand	Faculty of dentistry, Mahidol university	Rajthevi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (6)

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. — View 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. Review. — View 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.

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	amount of intraoperative fentanyl	Record the amount of fentanyl used in the operation.	intraoperatve period	Yes
Secondary	time to eye opening	the time that counted from closed anesthetic drugs and reversed muscle relaxant to patients eye opening.	emergence of anesthesia	Yes
Secondary	time to follow verbal command	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.	emergence of anesthesia	Yes
Secondary	time to extubation	the time that counted from closed anesthetic drugs and reversed muscle relaxant to remove the nasotracheal tube.	emergence of anesthesia	Yes
Secondary	postoperative pain score at 30 minute	postoperative pain score at 30 minute using 10-point pain assessment scale.	early postoperative period	Yes
Secondary	postoperative pain score at 60 minute	postoperative pain score at 60 minute using 10-point pain assessment scale.	early postoperative period	Yes
Secondary	amount of pethidine	Record the amount of pethidine that used for a pain killer when pain score more than 4 in first 2 hours post-operation.	early postoperative period (first 2 hours)	Yes