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

NCT03132259 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2017-05-30

No results posted yet for this study

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

Conditions

  • Pituitary Tumor

Interventions

DRUG

high dose dexmedethomidine

Dexmedethomidine continuous drip 0.5 mcg/kg/hr a

DRUG

low dose dexmedethomidine

Dexmedethomidine continuous drip 0.2 mcg/kg/hr

Sponsors & Collaborators

  • Mahidol University

    lead OTHER

Principal Investigators

  • Saipin Muangman, physician · Mahidol University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2017-05-31
Completion
2018-06-30

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03132259 on ClinicalTrials.gov