Remifentanil vs. Nicardipine for Controlled Hypotension in Elective Nasal Surgery
2026年6月16日 更新者：Fikret Salık、Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Comparison of Remifentanil and Nicardipine Infusions for Controlled Hypotension in Elective Nasal Surgery Where Bleeding Control is Critical: A Randomized Controlled Trial
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
44
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Fikret Salık
- 电话号码：+905076214125
- 邮箱：fikretsalik@gmail.com
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Nicardipine Group
Nicardipine infusion administered to achieve controlled hypotension (target MAP 55-65 mmHg) under general anesthesia prior to elective nasal surgery.
Standard institutional protocol applied.
|
Nicardipine infusion administered to achieve controlled hypotension (target MAP 55-65 mmHg) under general anesthesia prior to elective nasal surgery.
Standard institutional protocol applied.
|
|
有源比较器：Remifentanil Group
Remifentanil infusion administered to achieve controlled hypotension (target MAP 55-65 mmHg) under general anesthesia prior to elective nasal surgery.
Standard institutional protocol applied.
|
Remifentanil infusion administered to achieve controlled hypotension (target MAP 55-65 mmHg) under general anesthesia prior to elective nasal surgery.
Standard institutional protocol applied.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Surgical Field Quality
大体时间：Intraoperative period, approximately up to 3 hours
|
Intraoperative surgical field visibility assessed by the surgeon using the Fromme-Boezaart Bleeding Scale (scale 0-5; 0 = no bleeding, cadaveric field; 5 = severe bleeding, surgery not possible; lower scores indicate better surgical field)
|
Intraoperative period, approximately up to 3 hours
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Extubation Time
大体时间：End of surgery through extubation, approximately up to 30 minutes
|
Time from discontinuation of anesthetic agents to successful extubation (minutes)
|
End of surgery through extubation, approximately up to 30 minutes
|
|
Time Spent Within Target MAP Range
大体时间：Intraoperative period, approximately up to 2 hours
|
Duration of intraoperative period during which mean arterial pressure remained within the target range of 55-65 mmHg (minutes)
|
Intraoperative period, approximately up to 2 hours
|
|
Aldrete Recovery Score
大体时间：At 15 and 30 minutes post-extubation, up to 2 hours
|
Postoperative recovery assessed using the Aldrete Score (scale 0-10; higher scores indicate better recovery; score ≥ 9 required for PACU discharge)
|
At 15 and 30 minutes post-extubation, up to 2 hours
|
|
Time to PACU Discharge
大体时间：Post-extubation through PACU discharge, up to 2 hours
|
Time from arrival to PACU to meeting discharge criteria (minutes)
|
Post-extubation through PACU discharge, up to 2 hours
|
|
Heart Rate
大体时间：Intraoperative period, approximately up to 2 hours
|
Intraoperative heart rate monitored via standard ECG (beats per minute)
|
Intraoperative period, approximately up to 2 hours
|
|
Mean Arterial Pressure (MAP)
大体时间：Intraoperative mean arterial pressure monitored via non-invasive blood pressure measurement (mmHg)
|
Intraoperative mean arterial pressure monitored via non-invasive blood pressure measurement (mmHg)
|
Intraoperative mean arterial pressure monitored via non-invasive blood pressure measurement (mmHg)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年6月25日
初级完成 (估计的)
2026年7月1日
研究完成 (估计的)
2026年7月15日
研究注册日期
首次提交
2026年6月11日
首先提交符合 QC 标准的
2026年6月16日
首次发布 (实际的)
2026年6月22日
研究记录更新
最后更新发布 (实际的)
2026年6月22日
上次提交的符合 QC 标准的更新
2026年6月16日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.