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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.
Full description
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.
Enrollment
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Inclusion criteria
1): Planned to undergo laparoscopic hepatectomy.
2): Has signed the informed consent form.
3): Aged 18 to 80 years.
4): Body Mass Index (BMI) ranging from 18 to 28 kg/m².
5): American Society of Anesthesiologists (ASA) physical status classification I to III.
Exclusion criteria
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.
Primary purpose
Allocation
Interventional model
Masking
82 participants in 2 patient groups
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Central trial contact
Yueling Wang, resident
Data sourced from clinicaltrials.gov
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