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AnesthesiaNCT02083055

Anesthetic Advantages of Dexmedetomidine for Hypotensive Anesthesia

A study testing Dexmedetomidine and Nitroglycerin in people with Anesthesia and Hypotension, run by Mahidol University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Anesthesia, Hypotension
What is being tested?
Dexmedetomidine and Nitroglycerin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteThailand
Study dates
Dec 2012to Feb 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • systemic diseases not given informed consent

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Faculty of dentistry, Mahidol university

    Rajthevi, Bangkok, 10400

Other trials in Thailand

About this study

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

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.

Read the 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.

Being tested
Dexmedetomidine, Nitroglycerin
Keywords
dexmedetomidine, controlled hypotensive anesthesia
Medical subject headings
Hypotension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexmedetomidineDrug

    Also called precedex

    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

  • NitroglycerinDrug

    Also called nitrocine

    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.

Study groups in NCT02083055
Study groupRoleWhat they receive
dexmedetomidineExperimentalIntraoperative controlled hypotension by dexmedetomidine
Receives: Drug: Dexmedetomidine
nitroglycerinActive comparatorIntraoperative controlled hypotension by nitroglycerin
Receives: Drug: Nitroglycerin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. amount of intraoperative fentanyl

    Record the amount of fentanyl used in the operation.

    Measured: intraoperatve period

Secondary outcomes (6)

  1. time to eye opening

    the time that counted from closed anesthetic drugs and reversed muscle relaxant to patients eye opening.

    Measured: emergence of anesthesia

  2. 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.

    Measured: emergence of anesthesia

  3. time to extubation

    the time that counted from closed anesthetic drugs and reversed muscle relaxant to remove the nasotracheal tube.

    Measured: emergence of anesthesia

  4. postoperative pain score at 30 minute

    postoperative pain score at 30 minute using 10-point pain assessment scale.

    Measured: early postoperative period

  5. postoperative pain score at 60 minute

    postoperative pain score at 60 minute using 10-point pain assessment scale.

    Measured: early postoperative period

  6. 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.

    Measured: early postoperative period (first 2 hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2014 (estimated)
  2. Study startDec 2012
  3. Primary completionFeb 2014
  4. Study completionFeb 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02083055
Sponsor's protocol ID
MU-DT/PY-IRB 2012/021.1904
Status last verified
Mar 2014
First submitted
6 Mar 2014
Last updated
11 Mar 2014
Results posted
No
Data monitoring committee
No

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.

    PubMed 20006165

  • 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.

    PubMed 21724315

  • 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.

    PubMed 21195531

  • 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.

    PubMed 18511238

  • 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.

    PubMed 11286449

  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing Dexmedetomidine and Nitroglycerin in people with Anesthesia and Hypotension, run by Mahidol University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

amount of intraoperative fentanyl (time frame: intraoperatve period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02083055, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2014.

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