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Dexmedetomidine for Hemodynamic Control in Thyroid Tumor Resection
NCT07434206Phase 3
Key facts
- Status
- Active, not recruiting
- Start
- Apr 2024
- Primary completion
- Mar 2026
- Countries
- 1
- Sponsor
- South Egypt Cancer Institute
- Modality
- Small Molecules
- Drugs
- dexmedetomidine
- Conditions
- thyroid neoplasm
01
Overview
Phase 3, randomised, double-blind trial of dexmedetomidine in thyroid neoplasm (2 arms), sponsored by South Egypt Cancer Institute. Primary endpoint: Intraoperative hemodynamics. Started Apr 2024; status: active, not recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Labetalol Group
Initial bolus dose of labetalol 20 mg before surgical incision, followed by additional injections or continuous infusion to control BP.
Dexmedetomidine Group
IV bolus dose of 0.5-1 μg/kg of dexmedetomidine over 10 min before surgical incision, followed by IV infusion of 0.2 - 0.7 μg/kg/h.
03
Who it enrols
Adult patients aged 20-65 with active thyroid tumors undergoing resection, ASA I-III, NYHA I-II, BMI <= 40, excluding pregnant women and those with preoperative opioid use or cardiovascular contraindications.
04
Endpoints
Primary
Intraoperative hemodynamics
Secondary
Intensity of pain
Sedation
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