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临床试验/NCT05785234
NCT05785234招募中不适用

The Effects of Sufentanil-remimazolam vs. Remifentanil-remimazolam Total Intravenous Anesthesia on Postoperative Pain in Laparoscopic-assisted Gastrectomy - A Randomized, Controlled Study-

Yonsei University1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2023年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
66
试验地点
1
主要终点
Total consumption of fentanyl in 24 hours after surgery

研究概览

简要总结

In this study, the investigators evaluate the effect of total intravenous anesthesia using sufentanil-remimazolam and remifentanil-remimazolam on postoperative pain in patients undergoing laparoscopic gastrectomy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • 20years or older
  • Scheduled for laparoscopic-assisted gastrectomy
  • American Society of Anesthesiologists(ASA) physical status I and III

排除标准

  • Emergency operation
  • Patients with a history of severe hypersensitivity reaction to dextran 40
  • Patients who cannot use patient controlled analgesia(PCA)
  • Patients with morbid obesity [body mass index (BMI) >35 kg/m2]
  • Patients with history of uncontrolled hypertension (diastolic BP >110mmHg) or DM
  • Patients with history of heart failure (unstable angina, congestive heart failure)
  • Patients with history of liver failure, renal failure, allergic to medicine
  • Patients with history of cerebrovascular disease (cerebral hemorrhage, cerebral ischemia)
  • Patients with history of uncontrolled psychiatric disease (PTSD, anxiety, depression)
  • Patients with obstructive sleep apnea
  • Patients who cannot read the consent form (examples: Illiterate, foreigner)
  • Patients who withdraw the consent

研究组 & 干预措施

Sufentanil-remimazolam group

Experimental

The sufentanil-remimazolam group receives total intravenous anesthesia with sufentanil-remimazolam.

干预措施: sufentanil-remimazolam group (Drug)

Remifentanil-remimazolam group

Active Comparator

The remifentanil-remimazolam group receives total intravenous anesthesia with remifentanil-remimazolam.

干预措施: remifentanil-remimazolam group (Drug)

结局指标

主要结局

Total consumption of fentanyl in 24 hours after surgery

时间窗: after 24 hours postoperative period

To investigate the effect of total intravenous anesthesia with intraoperative sufentanil-remimazolam and remifentanil-remimazolam on postoperative pain, total cumulative dose of fentanyl was measured for the first postoperative 24 hour.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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