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临床试验/NCT05344911
NCT05344911已完成4 期

Comparison of Postoperative Pain Application of Alfentanil or Remifentanil in TIVA Undergoing Functional Endoscopic Sinus Surgery

Xijing Hospital1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2022年4月29日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
130
试验地点
1
主要终点
VAS score

研究概览

简要总结

Total intravenous anesthesia (TIVA) is maintained by intermittent or continuous combined intravenous injection of a variety of short-acting intravenous anesthetics, which can provide safe and rapid induction, maintenance and termination of general anesthesia. It has a slight effect on respiration and circulation, strong controllability, short anesthetic recovery time, reduced postoperative nausea and vomiting (PONV) and quick discharge time, so it has been widely used in clinic. Functional endoscopic sinus surgery is a common method for the treatment of sinusitis and other diseases. The trauma of this operation is less. The use of TIVA during the operation can reduce the bleeding in the surgical field and is beneficial to the recovery of patients.

The combination of propofol and remifentanil is the most common in TIVA because of its fast pharmacokinetics and short half-life. However, the disadvantage of remifentanil is the lack of residual analgesic effect after termination of continuous infusion. As postoperative nasal packing can still bring postoperative pain, patients with severe discomfort caused by pain will have unexpected conditions such as surgical incision cracking and bleeding, which will affect the effect of operation and rehabilitation. Afentanil is another opioid drug with short effect and strong analgesic effect. Previous studies have shown that remifentanil-based TIVA has slightly higher postoperative pain and early use of analgesics than TIVA in discectomy. Because the effect of TIVA using Afentanil or remifentanil on postoperative pain in functional nasal endoscopic surgery is not clear, this study intends to observe the effect of TIVA on postoperative pain in patients undergoing functional nasal endoscopic surgery under general anesthesia, so as to optimize the clinical anesthetic scheme of this kind of minimally invasive surgery and provide clinical reference.

详细描述

This study intends to observe the effect of TIVA using afentanil or remifentanil on postoperative pain in patients undergoing functional nasal endoscopic surgery under general anesthesia.

Main indicators:

VAS score at 30 min after operation.

Secondary indicators:

VAS score of 60 min after operation. VAS score of 24h after operation. Number of cases of postoperative use of analgesics . Number of cases of postoperative adverse reactions.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-65 years old
  • patients undergoing functional endoscopic sinus surgery under general anesthesia.

排除标准

  • Significant hypertension (diastolic blood pressure > 100mmHg) or hypotension (systolic . blood pressure < 100mmHg).
  • severe mental, cardiovascular, kidney or liver disease.
  • previous history of alcohol or drug abuse.
  • long-term use of painkillers before operation.
  • contraindications for any drugs used in the study.

研究组 & 干预措施

remifentanil

Active Comparator

Anesthesia maintenance:target-controlled infusion of propofol combined with remifentanil)

干预措施: Propofol combined with remifentanil (Drug)

alfentanil

Experimental

Anesthesia maintenance:target-controlled infusion of propofol combined with afentanil

干预措施: Propofol combined with alfentanil (Drug)

结局指标

主要结局

VAS score

时间窗: Postoperative 30minutes

the digital rating scale (VAS) uses a number between 0 and 10 to indicate that there is no pain; a score of 1-3 means that a slight pain can be tolerated; a score of 4-6 indicates that it is bearable if it does not affect sleep; a score of 7-10 indicates that it is becoming more and more painful and unbearable, affecting appetite and sleep

次要结局

未报告次要终点

研究者

发起方
Xijing Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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