Comparison of Remifentanil and Nicardipine Infusions for Controlled Hypotension in Elective Nasal Surgery Where Bleeding Control is Critical: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 44
Study Overview
Brief Summary
This study compares remifentanil infusion versus nicardipine infusion for controlled hypotension during elective nasal surgery. Both agents are standard clinical methods. The study evaluates hemodynamic stability, surgical field quality (Fromme-Boezaart score), tissue perfusion, intraoperative blood loss, surgeon satisfaction, and perioperative adverse effects.
Detailed Description
This is a prospective, randomized, controlled, parallel-group, single-blind (outcomes assessor-blinded) clinical study. Forty-four patients (ASA I-II, age >18) undergoing elective nasal surgery will be randomized 1:1 using a computer-based random number generator with sealed envelope allocation. The intervention group will receive nicardipine infusion; the control group will receive remifentanil infusion. Both are standard controlled hypotension methods used routinely at our institution. Hemodynamic parameters will be recorded at seven predefined time points. All perioperative measurements will be recorded by an independent blinded assessor. Statistical analysis: SPSS v24.0, p ≤ 0.05.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age > 18 years
- •ASA physical status I-II
- •Scheduled for elective nasal surgery
- •No known serious cardiovascular, respiratory, renal, or hepatic disease
- •No known allergy to remifentanil or nicardipine
- •No chronic use of beta-blockers, calcium channel blockers, or antihypertensive agents
- •Not pregnant or breastfeeding
- •BMI ≤ 35 kg/m²
- •No emergency surgical indication
- •Written informed consent obtained
Exclusion Criteria
- •Age < 18 years
- •ASA III or above
- •Known serious cardiovascular, respiratory, renal, or hepatic disease
- •Known allergy to remifentanil or nicardipine
- •Chronic use of beta-blockers, calcium channel blockers, or antihypertensive agents
- •Pregnancy or breastfeeding
- •Morbid obesity (BMI > 35 kg/m²)
- •Emergency surgery
- •Refusal to participate
Investigators
Fikret Salık
Medicine Doctor Associate Professor in Anesthesiology
Dicle University