The Effect of Remimazolam Versus Propofol on Postoperative Extubation Time
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Remimazolam, propofol.
- Who it may be relevant to
- Registry conditions: Laparoscopic Hepatectomy. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Remimazolam Versus Propofol on Postoperative Extubation Time in Patients Undergoing Laparoscopic Hepatectomy: A Randomized Controlled Trial
Overview
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.
Detailed 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.
Interventions
- Drug Remimazolam
Anesthesia induction: Intravenous injection of remimazolam 0.2-0.4 mg/kg. Anesthesia maintenance: Continuous infusion of remimazolam at 0.4-0.7mg/kg/h. - Drug propofol
Anesthesia induction: Intravenous injection of propofol 1.5-2.5 mg/kg. Anesthesia maintenance: Continuous infusion of propofol at 4-10 mg/kg/h.
Primary outcome measures
- Extubation time (minutes) [Time frame: From the time of cessation of intravenous sedative infusion until the time of tracheal extubation, up to 24 hours postoperatively.]
Secondary outcome measures (8)
- Incidence of Adverse Events During Anesthesia Emergence (per patient) [Time frame: From the time of cessation of continuous intravenous sedative infusion until the time of PACU discharge, up to 24 hours postoperatively.]
- PACU Length of Stay (minutes) [Time frame: From the time of PACU admission until the time of PACU discharge, up to 24 hours postoperatively.]
- Postoperative Hospital Stay (days) [Time frame: From the time of the end of surgery until the time of hospital discharge, up to 30 days postoperatively.]
- Incidence of Postoperative Complications (per patient) [Time frame: From the time of the end of surgery until the time of hospital discharge, up to 30 days postoperatively.]
- Mean Arterial Pressure (mmHg) [Time frame: From the time of patient entering the operating room until the time of PACU admission, up to 24 hours postoperatively.]
- Heart Rate (bpm) [Time frame: From the time of patient entering the operating room until the time of PACU admission, up to 24 hours postoperatively.]
- Stroke Volume Variation (%) [Time frame: From the time of patient entering the operating room until the time of PACU admission, up to 24 hours postoperatively.]
- Cardiac Index (L/min/m²) [Time frame: From the time of patient entering the operating room until the time of PACU admission, up to 24 hours postoperatively.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Other
Study locations
China · 1 center
- The First Affiliated Hospital of Sun Yat-sen University — Guangzhou
Identifiers
NCT: NCT07611344 · IRB[2025]680