跳至主要内容
临床试验/NCT07659496
NCT07659496尚未招募不适用

The Effects of Remifentanil Monotherapy Versus Remifentanil-Nicardipine Combination on Advanced Hemodynamic Parameters for Controlled Hypotension During Otolaryngological Surgery

Dicle University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年6月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1

研究概览

简要总结

Controlled hypotension is a widely employed technique in otolaryngological (ear, nose, and throat) surgery, primarily aimed at improving surgical field visibility and minimizing intraoperative blood loss. By maintaining mean arterial pressure within a targeted range, this approach facilitates a clearer operative field, reduces the need for blood transfusion, and shortens operative time, thereby contributing to improved surgical outcomes.

Among the pharmacological agents used to achieve controlled hypotension, remifentanil - an ultra-short-acting synthetic opioid - has gained widespread acceptance due to its rapid onset, predictable offset, and favorable hemodynamic profile. Nicardipine, a second-generation dihydropyridine calcium channel blocker, is also utilized for its potent vasodilatory properties and titratable antihypertensive effect. When used in combination, these two agents may offer complementary mechanisms of action; however, their combined impact on advanced hemodynamic parameters remains insufficiently characterized in the otolaryngological surgical setting.

The primary aim of this study is to compare the effects of remifentanil monotherapy versus remifentanil-nicardipine combination therapy on advanced hemodynamic parameters, cardiac physiology, and tissue perfusion in patients undergoing controlled hypotension during otolaryngological surgery. Advanced hemodynamic monitoring - including parameters such as cardiac output, stroke volume, systemic vascular resistance, and oxygen delivery indices - will provide a more comprehensive physiological assessment beyond conventional blood pressure measurements.

As secondary objectives, this study will evaluate and compare both regimens with respect to surgical field quality, surgeon satisfaction, intraoperative hemodynamic stability, and perioperative adverse effects. It is anticipated that a thorough comparative analysis of these two approaches will contribute to evidence-based anesthetic decision-making and help optimize patient safety and surgical outcomes in otolaryngological procedures.

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged > 18 years
  • American Society of Anesthesiologists (ASA) physical status I-II
  • Scheduled to undergo otolaryngological surgery under general anesthesia
  • Provision of written informed consent

排除标准

  • Aged < 18 years
  • ASA physical status III or higher
  • Known severe cardiovascular (coronary artery disease, heart failure, uncontrolled hypertension), respiratory, renal, or hepatic disease
  • Known allergy to the study drugs (remifentanil, nicardipine)
  • Chronic use of beta-blockers, calcium channel blockers, or any other medication affecting blood pressure
  • Pregnancy or breastfeeding
  • Morbid obesity
  • Emergency surgery requirement
  • Refusal to participate in the study

研究者

发起方
Dicle University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayhan Kaydu

Medicine Doctor Associate Professor in Anesthesiology

Dicle University

研究点 (1)

Loading locations...

相似试验

Remifentanil Monotherapy vs.... | 临床试验