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Comparison of the Effects of Remimazolam versus Propofol on Postoperative Sleep Quality in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Controlled Trial

Comparison of the Effects of Remimazolam and Propofol on Postoperative Sleep Quality in Patients Undergoing Laparoscopic Cholecystectomy

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122739
Enrollment
Unknown
Registered
2026-04-17
Start date
2026-04-17
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

postoperative sleep disturbances

Interventions

Remimazolam group:Remimazolam anesthesia

Sponsors

Renshou County People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. Patients undergoing laparoscopic cholecystectomy under general anaesthesia with endotracheal intubation; the estimated duration of surgery is within 1 hour; 2. Aged 18–64 years; gender is not restricted; 3. ASA Class I–II; 4. BMI between 18 kg/m² and 30 kg/m²; 5. Pittsburgh Sleep Quality Index (PSQI) score <= 7, Athens Insomnia Scale (AIS) score < 4; 6. Hospital Anxiety and Depression Scale (HADS) score <= 7; 7. Informed consent: voluntary participation in this trial, with the patient personally signing the informed consent form

Exclusion criteria

Exclusion criteria: 1. Patients unable to complete the Pittsburgh Sleep Quality Index (PSQI), the Athens Insomnia Scale (AIS) or the Hospital Anxiety and Depression Scale (HADS); 2. Patients with severe concomitant cardiovascular, cerebrovascular, hepatic or renal disease; 3. Patients receiving long-term treatment with opioid analgesics, sedatives or non-steroidal anti-inflammatory drugs; 4. Patients with a history of mental illness; 5. Patients who have participated in other drug or device clinical trials within the three months prior to the screening period; 6. Patients deemed unsuitable for this clinical trial by the investigator; 7. Patients unwilling to participate in the clinical trial.

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index (PSQI) score;

Secondary

MeasureTime frame
Athens Insomnia Scale (AIS) scores;Resting Visual Analog Scale (VAS) pain scores;C-reactive protein (CRP) levels;Neutrophil and lymphocyte counts;Duration of surgery;Hemodynamic parameters;

Countries

China

Contacts

Public ContactDanni Li

Renshou County People's Hospital

ldn137955@163.com+86 137 9554 5609

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026