Comparison of Remifentanil and Nicardipine Infusions for Controlled Hypotension in Elective Nasal Surgery Where Bleeding Control is Critical: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究者
Fikret Salık
Medicine Doctor Associate Professor in Anesthesiology
Dicle University