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A multicenter, randomized, positive-controlled clinical study on the efficacy and safety of remimazolam besylate for induction and maintenance of general anesthesia in patients undergoing abdominal laparoscopic surgery

A multicenter, randomized, positive-controlled clinical study on the efficacy and safety of remimazolam besylate for induction and maintenance of general anesthesia in patients undergoing abdominal laparoscopic surgery

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600119420
Enrollment
Unknown
Registered
2026-02-26
Start date
2024-05-06
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing laparoscopic surgery

Interventions

Group R1:Remimazolam 6mg/kg/h is used for anesthesia induction in the first part of the study, and Remimazolam 1mg/kg/h is used for anesthesia maintenance in the second part of the study.
Group R2:Remimazolam 12mg/kg/h is used for anesthesia induction in the first part of the study, and Remimazolam 1.5mg/kg/h is used for anesthesia maintenance in the second part of the study.
Group P:Propofol 2mg/kg is used for anesthesia induction in the first part of the study, and Propofol 4-10mg/kg/h is used for anesthesia maintenance in the second part of the study.

Sponsors

The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 65 years of both sexes,; 2. ASA physical status I or II; 3. BMI 18 to 30 kg/m^2; 4. Abdominal endoscopic elective surgery under general anesthesia is required, and tracheal intubation is also necessary; 5. Be able to understand and voluntarily sign the informed consent form, and be willing to abide by the requirements of the trial protocol.

Exclusion criteria

Exclusion criteria: 1. Those who are allergic to or contraindicated to benzodiazepines, opioids, propofol, flumaciclib, naloxone and their drug components; 2. Patients with severe heart, lung and kidney insufficiency, combined with multiple chronic diseases who cannot tolerate surgical anesthesia, as well as those with mental disorders; 3. Those with a history of alcohol abuse, opioid allergy or abuse of such drugs; 4. Patients with uncontrolled severe hypertension; 5. Emergency surgery patients; 6. Pregnant or lactating women; 7. Other circumstances that the researchers consider unsuitable for enrollment.

Design outcomes

Primary

MeasureTime frame
MOAA/S score;Bispectral Index, BIS;blood pressure;heart rate;

Secondary

MeasureTime frame
Tracheal intubation time;The number of cases of adverse cardiovascular events;Dosage of cardiovascular active drugs;Eye-opening time;Extubation time;State your ID number and the time;Exit time;The occurrence frequency of adverse events;The total amount of clinical treatment drugs;The number of patients using flumacinib;The number of patients Learned during the operation;

Countries

China

Contacts

Public ContactWang Sheng

The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China

iamsheng2006@163.com+86 191 5600 7726

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026