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

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ClinicalTrials.gov Identifier: NCT03132259
Recruitment Status : Recruiting
First Posted : April 27, 2017
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
SMuangman, Mahidol University

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Pituitary Tumor Drug: high dose dexmedethomidine Drug: low dose dexmedethomidine Phase 4

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  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Low and High Dose of Dexmedethomidine Can Stabilize Hemodynamics and Blood Loss in Pituitary Tumor Removal by Transphenoid Approach
Study Start Date : May 2016
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High dose dexmedethomidine
High dose is 0.5 microgram/kg/hr
Drug: high dose dexmedethomidine
Dexmedethomidine continuous drip 0.5 mcg/kg/hr a
Other Name: Precedex

Experimental: Low dose dexmedethomidine
Low dose is 0.2 microgram/kg/hr
Drug: low dose dexmedethomidine
Dexmedethomidine continuous drip 0.2 mcg/kg/hr




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03132259


Contacts
Contact: Saipin Muangman, physician 6681 3747786 saipinnoolek@gmail.com
Contact: Sirinuttakul Akkaworakit, physician 087- 675-8434 gnig.ging@gmail.com

Locations
Thailand
Faculy of Medicine Siriraj hospital Mahidol University Recruiting
Bangkok, Thailand, 10700
Contact: Saipin Muangman, physician         
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Saipin Muangman, physician Mahidol University

Publications of Results:
Responsible Party: SMuangman, Assisted Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT03132259     History of Changes
Other Study ID Numbers: 116/2559
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by SMuangman, Mahidol University:
Dexmedethomidine

Additional relevant MeSH terms:
Pituitary Diseases
Pituitary Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases