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

Phase 4

• Conditions: Pituitary Tumor
• Interventions: Drug: high dose dexmedethomidine; Drug: low dose dexmedethomidine

• Registration Number: NCT03132259
• Lead Sponsor: 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

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-07-18
• Study First Submitted QC: 2017-04-24
• Study First Posted: 2017-04-27
• Status Verified: 2017-05
• Primary Completion: 2017-05
• Last Update Submitted: 2017-05-25
• Last Update Posted: 2017-05-30
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 124

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High dose dexmedethomidine	high dose dexmedethomidine	High dose is 0.5 microgram/kg/hr
Low dose dexmedethomidine	low dose dexmedethomidine	Low dose is 0.2 microgram/kg/hr

Primary Outcome Measures

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

Name	Time	Method
Comparative Low and High Dose of Dexmedethomidine in Pituitary Tumor	24 hours	Low dose is 0.2microgram/kg/hr High dose is 0.5 microgram/kg/hr how much dose blood loss

Trial Locations

Locations (1)

Faculy of Medicine Siriraj hospital Mahidol University; 🇹🇭 Bangkok, Thailand