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Efficacy and Safety of Remimazolam Tosylate for General Anesthesia in Laparoscopic Surgery: A Multicenter, Prospective, Observational Cohort Study

Efficacy and Safety of Remimazolam Tosylate for General Anesthesia in Laparoscopic Surgery: A Multicenter, Prospective, Observational Cohort Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600128270
Enrollment
Unknown
Registered
2026-07-16
Start date
2026-07-31
Completion date
Unknown
Last updated
2026-07-20

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

Conditions

Postoperative recovery after laparoscopic surgery

Interventions

Observation group:None

Sponsors

The First Affiliated Hospital of University of Science and Technology of China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >=18 years old, gender not limited; 2. Laparoscopic surgery under general anesthesia with tracheal intubation will be performed as scheduled. The operation duration is expected to be 1 to 2 hours, including but not limited to: cholecystectomy, inguinal hernia repair, hysterectomy, and oophorectomy. 3. It is planned to use remimazolam mesylate during the maintenance phase of anesthesia, which can be combined with propofol or sevoflurane infusion. The interval between the discontinuation of the two general anesthetics during the maintenance phase should not exceed 5 minutes. 4. Participate voluntarily and sign the informed consent form;

Exclusion criteria

Exclusion criteria: 1. Planned to sequentially use remimazolam tosylate with propofol or sevoflurane during the maintenance phase of anesthesia. 2. Pre-existing comorbidities that may significantly affect the quality of anesthesia emergence, such as encephalopathy, sepsis, hypoglycemia, severe electrolyte disturbances (e.g., serum sodium >160 mmol/L or =10), hypoalbuminemia, or clinical hypothyroidism. 3. Patients who have continuously used benzodiazepines within 3 months before surgery. 4. Patients who have used benzodiazepines, opioids, neuromuscular blocking agents, or any sedative-hypnotic drugs within 7 days before surgery. 5. Patients with known allergy to any component of propofol, sevoflurane, benzodiazepines, or remimazolam tosylate. 6. Patients with myasthenia gravis, schizophrenia, or severe depressive states. 7. Pregnant or breastfeeding women. 8. Other conditions that, in the investigator's opinion, make the patient unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Composite endpoint(successful anesthesia and no delayed emergence);

Secondary

MeasureTime frame
The incidence of delirium;The Qor-15 score;The proportion of successful anesthesia;The incidence of intraoperative awareness;Loss of consciousness duration;The incidence of hypotension;Serum inflammatory factor levels;The proportion of no delayed emergence;The incidence of nausea and vomiting within 24 hours after the operation;Time of extubation;The dosage of anesthetic and analgesic drugs used during the operation;

Countries

China

Contacts

Public ContactWang Sheng

The First Affiliated Hospital of University of Science and Technology of China

iamsheng2020@ustc.edu.cn+86 551 62282052

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026