NCT02083055

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 6, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 11, 2014

Completed
Last Updated

March 11, 2014

Status Verified

March 1, 2014

Enrollment Period

1.2 years

First QC Date

March 6, 2014

Last Update Submit

March 6, 2014

Conditions

AnesthesiaHypotension

Keywords

dexmedetomidinecontrolled hypotensive anesthesia

Outcome Measures

Primary Outcomes (1)

  • amount of intraoperative fentanyl

    Record the amount of fentanyl used in the operation.

    intraoperatve period

Secondary Outcomes (6)

  • time to eye opening

    emergence of anesthesia

  • time to follow verbal command

    emergence of anesthesia

  • time to extubation

    emergence of anesthesia

  • postoperative pain score at 30 minute

    early postoperative period

  • postoperative pain score at 60 minute

    early postoperative period

  • +1 more secondary outcomes

Study Arms (2)

dexmedetomidine

EXPERIMENTAL

Intraoperative controlled hypotension by dexmedetomidine

Drug: Dexmedetomidine

nitroglycerin

ACTIVE COMPARATOR

Intraoperative controlled hypotension by nitroglycerin

Drug: Nitroglycerin

Interventions

DexmedetomidineDRUG

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

Also known as: precedex
dexmedetomidine
NitroglycerinDRUG

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.

Also known as: nitrocine
nitroglycerin

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients who undergo bimaxillary surgery physical status I according to the classification of the American Society of Anesthesiologist age 18-45 years

You may not qualify if:

  • systemic diseases not given informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dentistry, Mahidol university

Rajthevi, Bangkok, 10400, Thailand

Location

Related 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.

    PMID: 20006165BACKGROUND

  • 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.

    PMID: 21724315BACKGROUND

  • 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.

    PMID: 21195531BACKGROUND

  • 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.

    PMID: 18511238BACKGROUND

  • 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.

    PMID: 11286449BACKGROUND

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Hypotension

Interventions

DexmedetomidineNitroglycerin

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNitro CompoundsOrganic Chemicals

Study Officials

  • Duangdee Rummasak, M.D.

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
department of oral and maxillofacial surgery, faculty of dentistry

Study Record Dates

First Submitted

March 6, 2014

First Posted

March 11, 2014

Study Start

December 1, 2012

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

March 11, 2014

Record last verified: 2014-03

Locations

TH(1)