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

Study Overview
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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

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

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

Conditions
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Pituitary Tumor

Intervention / Treatment
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* Drug: high dose dexmedethomidine
* Drug: low dose dexmedethomidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age18-65 ASA 1-2 Elective TNTS resection of Pituitary Tumor No narcotic before surgery as premedication Able to Extubate Exclusion Criteria: GCS less than 15 Preoperative Heart Rate less than 50 beat/min No Beta-Blockers Pregnant patients Take any Alpha-Methyldopa, Clonodine, Other Alpha-2 Adrenergic Agonist Hemodynamic unstable Systolic BP more than 160mmHg CAD Renal insuffuciency Allergy in dexmedethomidine and opioid BMI more than 30 Denied consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High dose dexmedethomidine<br>High dose is 0.5 microgram/kg/hr | Drug: high dose dexmedethomidine<br>* Dexmedethomidine continuous drip 0.5 mcg/kg/hr a<br>* Other names: Precedex;|
| Experimental: Low dose dexmedethomidine<br>Low dose is 0.2 microgram/kg/hr | Drug: low dose dexmedethomidine<br>* Dexmedethomidine continuous drip 0.2 mcg/kg/hr<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexmedethomidine