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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2018-06-30

Brief Summary

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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

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Detailed Description

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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

Conditions

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Pituitary Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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High dose dexmedethomidine

High dose is 0.5 microgram/kg/hr

Group Type EXPERIMENTAL

high dose dexmedethomidine

Intervention Type DRUG

Dexmedethomidine continuous drip 0.5 mcg/kg/hr a

Low dose dexmedethomidine

Low dose is 0.2 microgram/kg/hr

Group Type EXPERIMENTAL

low dose dexmedethomidine

Intervention Type DRUG

Dexmedethomidine continuous drip 0.2 mcg/kg/hr

Interventions

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high dose dexmedethomidine

Dexmedethomidine continuous drip 0.5 mcg/kg/hr a

Intervention Type DRUG

low dose dexmedethomidine

Dexmedethomidine continuous drip 0.2 mcg/kg/hr

Intervention Type DRUG

Other Intervention Names

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Precedex

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes