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临床试验/NCT06777758
NCT06777758招募中4 期

The Comparison of Remimazolam or Propofol Used Alone Versus in Combination for Moderate Sedation During Endoscopic Examination and Treatment.

Kaohsiung Veterans General Hospital.1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年2月12日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
入组人数
90
试验地点
1
主要终点
Dose change

研究概览

简要总结

This study aims to evaluate the efficacy and safety of Remimazolam, either used alone or in combination with Propofol, for moderate sedation anesthesia during endoscopic therapies or examinations. Additionally, it seeks to explore whether their combination can further enhance the quality of patient anesthesia and recovery outcomes.

详细描述

Objective This study aims to evaluate the efficacy and safety of Remimazolam, either used alone or in combination with Propofol, for moderate sedation anesthesia during endoscopic therapies or examinations. Additionally, it seeks to explore whether their combination can further enhance the quality of patient anesthesia and recovery outcomes.

Methods The investigators will conduct a prospective, randomized, single-center study. Eligible patients will be randomly allocated into three groups: the first group receiving Propofol alone for moderate sedation anesthesia (control group), the second group receiving Remimazolam alone for anesthesia, and the third group receiving a combination of Propofol and Remimazolam for anesthesia. The investigators will record anesthesia depth (DSA values of BIS), heart rate, blood pressure, oxygen saturation, and other indicators during the procedure, as well as postoperative recovery time, time to consciousness recovery, oxygen desaturation, instances of inadequate anesthesia depth, intraoperative patient movement or recall, surgeon satisfaction, patient satisfaction, readmission rate within 14 days, complications, and length of hospital stay.

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
None

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects are between 20-80 years old.
  • Anesthesiologists rated ASA as between I and III.
  • Patients undergoing upper gastrointestinal endoscopic examination or therapy.

排除标准

  • Allergy to Propofol, Remimazolam, or opioid medications.
  • Emergency surgery.
  • Pregnancy.
  • History of malignant hyperthermia.
  • Impaired liver or kidney function.
  • Airway difficulties due to pharyngeal tumors.
  • Refusal to participate.

研究组 & 干预措施

Remimazolam

Experimental

The patient underwent routine upper gastrointestinal endoscopy and Remimazolam was substituted for Propofol.

干预措施: Remimazolam (Drug)

Propofol + Remimazolam

Experimental

The patient underwent routine upper gastrointestinal endoscopy, and the anesthetic drug used was Propofol combined with Remimazolam.

干预措施: Remimazolam (Drug)

Propofol + Remimazolam

Experimental

The patient underwent routine upper gastrointestinal endoscopy, and the anesthetic drug used was Propofol combined with Remimazolam.

干预措施: Propofol (Drug)

Propofol

Active Comparator

The patient underwent a routine upper gastrointestinal endoscopy.

干预措施: Propofol (Drug)

结局指标

主要结局

Dose change

时间窗: Perioperatively (during upper gastrointestinal endoscopy)

Change in Propofol dose ratio. (Record total dose, Duration, mg/h/kg)

次要结局

  • Incidence of postoperative nausea and vomiting.(After returning to the ward from the recovery room until before breakfast on the first postoperative day.)
  • Time to open eyes after stopping Propofol or Remimazolam.(The timer starts after the anesthetic is administered.)
  • Use of rescue medications during surgery.(During surgery)
  • Analgesic dosage in the recovery room.(Observation period in the postoperative recovery room)
  • Analgesic dosage in the ward.(The patients were followed up from the time they returned to the ward after surgery to the first day after surgery.)
  • Pain Intensity (Visual Analog Scale, VAS) every 15 minutes in the recovery room for 1 hour after surgery.(Within 1 hour post-surgery.)
  • Pain from the first injection of medication.(During the surgery (immediately after the first injection).)
  • Recall of surgery events.(On postoperative day 1 (within 24 hours after surgery).)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yuan-Yi Chia

Department Director

Kaohsiung Veterans General Hospital.

研究点 (1)

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