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Comparison of the effects of remimazolam tosilate combined with sevoflurane general anesthesia versus sevoflurane general anesthesia on postoperative sleep disturbances in patients undergoing abdominal surgery: a prospective, randomized controlled study

Comparison of the effects of remimazolam tosilate combined with sevoflurane general anesthesia versus sevoflurane general anesthesia on postoperative sleep disturbances in patients undergoing abdominal surgery: a prospective, randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111978
Enrollment
Unknown
Registered
2025-11-07
Start date
2025-11-14
Completion date
Unknown
Last updated
2025-11-11

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

Conditions

Postoperative Sleep Disturbance

Interventions

Rebenin combined with sevoflurane general anesthesia group:Rebenin combined with sevoflurane general anesthesia
Sevoflurane general anesthesia group:Sevoflurane general anesthesia

Sponsors

Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Patients aged 18-75 years undergoing elective abdominal surgery; 2.Surgery and general anesthesia time >=2 hours, postoperative hospital stay at least 3 days; 3.ASA I-III, BMI < 30 kg/m^2; 4.No severe visual or hearing impairment, able to read; 5.Patients participate voluntarily and sign informed consent.

Exclusion criteria

Exclusion criteria: 1.History of allergy to benzodiazepines; 2.History or family history of malignant hyperthermia; 3.History of myasthenia gravis, dementia, schizophrenia, or major depressive disorder (MDD); 4.Poor general condition with a history of serious cardiovascular, respiratory, hepatic, renal, central nervous, or hematologic diseases, and may not survive more than 3 months; 5.Use of sedatives or antidepressants within the past week; 6.Alcoholism or drug dependence; 7.The patient has previously been enrolled in this study (applicable to patients undergoing a second abdominal surgery during the study period); 8.Patients with difficult airways; 9.Patients who cannot undergo long-term follow-up or have poor compliance; 10.Preoperative AIS baseline score >= 6.

Design outcomes

Primary

MeasureTime frame
Insomnia rate 3 days after surgery;—

Secondary

MeasureTime frame
Insomnia rate at 1 day, 7 days, 1 month, and 3 months post-surgery;Sleep quality score;Anxiety and Depression Status Scores;Postoperative recovery quality;Postoperative delirium ;Postoperative cognitive function;Perioperative EEG Spectrum;Postoperative recovery status;Postoperative pain;—

Countries

China

Contacts

Public ContactYujuan Li

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

yujuan_04@aloyun.com+86 159 1873 4156

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026