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Anesthetic Advantages of Dexmedetomidine for Hypotensive Anesthesia

Primary Purpose

Anesthesia, Hypotension

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Dexmedetomidine
Nitroglycerin
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthesia focused on measuring dexmedetomidine, controlled hypotensive anesthesia

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of dentistry, Mahidol university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

dexmedetomidine

nitroglycerin

Arm Description

Intraoperative controlled hypotension by dexmedetomidine

Intraoperative controlled hypotension by nitroglycerin

Outcomes

Primary Outcome Measures

amount of intraoperative fentanyl
Record the amount of fentanyl used in the operation.

Secondary Outcome Measures

time to eye opening
the time that counted from closed anesthetic drugs and reversed muscle relaxant to patients eye opening.
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.
time to extubation
the time that counted from closed anesthetic drugs and reversed muscle relaxant to remove the nasotracheal tube.
postoperative pain score at 30 minute
postoperative pain score at 30 minute using 10-point pain assessment scale.
postoperative pain score at 60 minute
postoperative pain score at 60 minute using 10-point pain assessment scale.
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.

Full Information

First Posted
March 6, 2014
Last Updated
March 6, 2014
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT02083055
Brief Title
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

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Hypotension
Keywords
dexmedetomidine, controlled hypotensive anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dexmedetomidine
Arm Type
Experimental
Arm Description
Intraoperative controlled hypotension by dexmedetomidine
Arm Title
nitroglycerin
Arm Type
Active Comparator
Arm Description
Intraoperative controlled hypotension by nitroglycerin
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
precedex
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Nitroglycerin
Other Intervention Name(s)
nitrocine
Intervention Description
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.
Primary Outcome Measure Information:
Title
amount of intraoperative fentanyl
Description
Record the amount of fentanyl used in the operation.
Time Frame
intraoperatve period
Secondary Outcome Measure Information:
Title
time to eye opening
Description
the time that counted from closed anesthetic drugs and reversed muscle relaxant to patients eye opening.
Time Frame
emergence of anesthesia
Title
time to follow verbal command
Description
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.
Time Frame
emergence of anesthesia
Title
time to extubation
Description
the time that counted from closed anesthetic drugs and reversed muscle relaxant to remove the nasotracheal tube.
Time Frame
emergence of anesthesia
Title
postoperative pain score at 30 minute
Description
postoperative pain score at 30 minute using 10-point pain assessment scale.
Time Frame
early postoperative period
Title
postoperative pain score at 60 minute
Description
postoperative pain score at 60 minute using 10-point pain assessment scale.
Time Frame
early postoperative period
Title
amount of pethidine
Description
Record the amount of pethidine that used for a pain killer when pain score more than 4 in first 2 hours post-operation.
Time Frame
early postoperative period (first 2 hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duangdee Rummasak, M.D.
Organizational Affiliation
faculty of dentistry, Mahidol university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of dentistry, Mahidol university
City
Rajthevi
State/Province
Bangkok
ZIP/Postal Code
10400
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
20006165
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.
Results Reference
background
PubMed Identifier
21724315
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.
Results Reference
background
PubMed Identifier
21195531
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.
Results Reference
background
PubMed Identifier
18511238
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.
Results Reference
background
PubMed Identifier
11286449
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.
Results Reference
background
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.
Results Reference
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Anesthetic Advantages of Dexmedetomidine for Hypotensive Anesthesia

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