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临床试验/NCT07611344
NCT07611344已完成4 期

The Effect of Remimazolam Versus Propofol on Postoperative Extubation Time in Patients Undergoing Laparoscopic Hepatectomy: A Randomized Controlled Trial

Xuyu Zhang2 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2026年5月31日最近更新:
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
82
试验地点
2

研究概览

简要总结

This clinical trial aims to help us understand how two drugs, Propofol and Remazoloam, affect when researchers remove a Participants' breathing tube after liver surgery (laparoscopic liver resection).The main research questions include: comparing the time to breathing tube removal between patients who receive each drug, comparing changes in heart rate and blood pressure during surgery, and comparing the rates of unwanted medical events after surgery. Researchers will give either Propofol or Remimazolam as a sedative medicine for anesthesia. This will allow the researchers to compare the time to breathing tube removal after surgery. Participants will complete their surgery according to a pre-planned surgical plan.

详细描述

This study is a clinical randomized controlled trial aimed at comparing the postoperative extubation time of remimazolam versus propofol in patients undergoing laparoscopic liver resection. Additionally, the study will compare intraoperative hemodynamic parameters, the incidence of adverse events during the anesthesia emergence period, length of stay in the post-anesthesia care unit (PACU), hospital length of stay, and the incidence of postoperative complications. Patients meeting the inclusion criteria will sign informed consent forms and be randomly assigned to one of two groups. Routine preoperative preparation will be performed. After entering the operating room, anesthesia induction and maintenance will be carried out according to the study protocol. After surgery, all patients will be transferred to the PACU. Extubation will be performed when extubation criteria are met, and patients will be returned to the ward when the Steward recovery score reaches ≥4. Data on postoperative extubation time, PACU stay, hospital length of stay, and postoperative complications will be recorded. Finally, data analysis and results reporting will be conducted.This trial can provide meaningful references for clinical drug selection. At the same time, this study will fill the gaps in clinical evidence in this field.

研究设计

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

入排标准

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

入选标准

  • : Planned to undergo laparoscopic hepatectomy.
  • : Has signed the informed consent form.
  • : Aged 18 to 80 years.
  • : Body Mass Index (BMI) ranging from 18 to 28 kg/m².
  • : American Society of Anesthesiologists (ASA) physical status classification I to III.

排除标准

  • 1): Severe cardiopulmonary dysfunction, or hepatic/renal dysfunction.
  • 2): Diagnosis of neuropsychiatric disorders.
  • 3): Pregnant or lactating women.
  • 4): A history of allergy or contraindication to benzodiazepines, propofol, or any of their components.

研究组 & 干预措施

Remimazolam

Experimental

干预措施: Remimazolam (Drug)

Propofol

Active Comparator

干预措施: propofol (Drug)

研究者

发起方
Xuyu Zhang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Xuyu Zhang

Full Professor

First Affiliated Hospital, Sun Yat-Sen University

研究点 (2)

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