Comparative Low and High Dose of Dexmedethomidine in Pituitary Tumor Removal by Transphenoid Approach

May 25, 2017 updated by: SMuangman, Mahidol University

Comparative Low and High Dose of Dexmedethomidine Can Stabilize Hemodynamics and Blood Loss in Pituitary Tumor Removal by Transphenoid Approach

Transnasal transsphenoidal (TNTS) resection of pituitary tumors involves wide fluctuation in hemodynamic parameter and causes hypertension and tachycardia due to intense noxious stimuli during various stages of surgery. None of routinely used anesthetic agents effectively blunts the undesirable hemodynamic responses, and therefore usually there is a need to use increased doses of anesthetic agents. Dexmedetomidine (DEX) an α-2 adrenergic receptor agonist, because its sympatholytic and antinociceptive properties may ensure optimal intraoperative hemodynamic stability during critical moments of surgical manipulation. In addition, DEX reduced the anesthetic requirement with rapid recovery at the end of surgery. The main aim of the study was to evaluate the effect of DEX on perioperative hemodynamics, anesthetic requirements

Study Overview

Detailed Description

DEX as an anesthetic adjuvant improved hemodynamic stability and decreased anesthetic requirements in patients undergoing TNTS resection of pituitary tumor. In addition, DEX provided better surgical field exposure conditions and early recovery from anesthesia

Study Type

Interventional

Enrollment (Anticipated)

124

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Sirinuttakul Akkaworakit, physician
  • Phone Number: 087- 675-8434
  • Email: gnig.ging@gmail.com

Study Locations

      • Bangkok, Thailand, 10700
        • Recruiting
        • Faculy of Medicine Siriraj hospital Mahidol University
        • Contact:
          • Saipin Muangman, physician

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age18-65
  2. ASA 1-2
  3. Elective TNTS resection of Pituitary Tumor
  4. No narcotic before surgery as premedication
  5. Able to Extubate

Exclusion Criteria:

  1. GCS less than 15
  2. Preoperative Heart Rate less than 50 beat/min
  3. No Beta-Blockers
  4. Pregnant patients
  5. Take any Alpha-Methyldopa, Clonodine, Other Alpha-2 Adrenergic Agonist
  6. Hemodynamic unstable
  7. Systolic BP more than 160mmHg
  8. CAD
  9. Renal insuffuciency
  10. Allergy in dexmedethomidine and opioid
  11. BMI more than 30
  12. Denied consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High dose dexmedethomidine
High dose is 0.5 microgram/kg/hr
Dexmedethomidine continuous drip 0.5 mcg/kg/hr a
Other Names:
  • Precedex
Experimental: Low dose dexmedethomidine
Low dose is 0.2 microgram/kg/hr
Dexmedethomidine continuous drip 0.2 mcg/kg/hr

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparative Low and High Dose of Dexmedethomidine in Pituitary Tumor Removal by Transphenoid Approach
Time Frame: 24 hours
Low dose is 0.2microgram/kg/hr High dose is 0.5 microgram/kg/hr what is the dose proper and hemodynamic changes. Hemodynamic change means BP is lower than 20% of baseline more than 10minute
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparative Low and High Dose of Dexmedethomidine in Pituitary Tumor
Time Frame: 24 hours
Low dose is 0.2microgram/kg/hr High dose is 0.5 microgram/kg/hr how much dose blood loss
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Saipin Muangman, physician, Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

May 1, 2017

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

July 18, 2016

First Submitted That Met QC Criteria

April 24, 2017

First Posted (Actual)

April 27, 2017

Study Record Updates

Last Update Posted (Actual)

May 30, 2017

Last Update Submitted That Met QC Criteria

May 25, 2017

Last Verified

May 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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