Anesthesia Clinical Trial
Official title:
Anesthetic Advantages of Dexmedetomidine Compared With Nitroglycerin for Hypotensive Anesthesia in Orthognathic Surgery. A Randomized Clinical Trial.
Verified date | March 2014 |
Source | Mahidol University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Thailand: Ethical Committee |
Study type | Interventional |
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Thailand | Faculty of dentistry, Mahidol university | Rajthevi | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Mahidol University |
Thailand,
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
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 |
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