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

Mahidol University

Status and phase: Unknown; Phase 4

Conditions: Pituitary Tumor

Treatments: Drug: high dose dexmedethomidine; Drug: low dose dexmedethomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT03132259

116/2559

Details and patient eligibility

About

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

Full 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

Enrollment: 124 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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124 participants in 2 patient groups

High dose dexmedethomidine

Experimental group

Description:

High dose is 0.5 microgram/kg/hr

Treatment:

Drug: high dose dexmedethomidine

Low dose dexmedethomidine

Experimental group

Description:

Low dose is 0.2 microgram/kg/hr

Treatment:

Drug: low dose dexmedethomidine