The Effect of Remimazolam on Postoperative Sleep Quality

NCT07094945 | Not Yet Recruiting Phase 4

• 1 other identifier: 2025S076
• Study Type: interventional
• Target: 260
• Locations: 0 countries
• Sites: N/A

Brief Summary

A large amount of clinical evidence shows that after surgery, especially major surgery, the sleep quality of patients often drops significantly immediately, with the most obvious decline on the first night after surgery, which can last for several days to several months. Remimazolam is a new type of benzodiazepine drug and a super-short-acting GABAA receptor agonist. Compared with propofol, remimazolam can largely avoid adverse reactions such as hemodynamic fluctuations, excessive sedation and injection pain caused by propofol. It has good safety and is superior to propofol. However, there are currently only a few clinical research results regarding the impact of remimazolam on the sleep quality of patients under general anesthesia or sedation. Therefore, this study intends to observe the effect of remimazolam on the sleep quality of patients in gynecological day surgery. It is expected that by optimizing the anesthesia plan, the postoperative sleep quality of patients can be improved, and ultimately the postoperative recovery of patients can be promoted.

Conditions

Gynecological Day Surgery

Outcome Measures

Primary Outcomes (1)

• Richard Campbell's Sleep Scale score

  Range: 0 points (optimal sleep) to 10 points (optimal sleep). Direction: The higher the score, the more severe the sleep problem

  The night of the first to third postoperative day

Secondary Outcomes (3)

• Blood Pressure

  Before anesthesia, before the insertion of the laryngeal mask, at the beginning of the operation, at the end of the operation, and when the laryngeal mask is removed

• Heart rate

  Before anesthesia, before the insertion of the laryngeal mask, at the beginning of the operation, at the end of the operation, and when the laryngeal mask is removed.

• Postoperative adverse reactions

  24 hours after the operation

Study Arms (2)

Remimazolam Grop

EXPERIMENTAL

Remimazolam 0.3mg/kg for induction and 0.6-1.0 mg/kg·h for maintenance of anesthesia

Drug: Remimazolam

Propofol Group

ACTIVE COMPARATOR

Propofol 2 mg/kg for induction and 4-12 mg/kg·h for maintenance of anesthesia

Drug: Propofol

Interventions

Remimazolam DRUG

Remimazolam 0.3 mg/kg is slowly injected intravenously until loss of consciousness. Remimazolam 0.6-1.0 mg/kg·h is used for anesthesia maintenance.

Remimazolam Grop

Propofol DRUG

Propofol 2 mg/kg is slowly injected intravenously until loss of consciousness. Remimazolam 4-12 mg/kg·h is used for anesthesia maintenance

Propofol Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA classification grades I - II.
• BMI: 18.5-24 kg/m ².
• Be able to correctly understand and complete the assessment scale independently.
• The operation time shall not exceed one hour.
• Informed consent for this research.

You may not qualify if:

• PSQI \> 7 points (with sleep disorders requiring medical intervention within the last month).
• Suffering from central nervous system diseases or mental disorders.
• Patients with sleep apnea syndrome or other serious respiratory diseases.
• Have functional disorders of important organs.
• Alcohol abuse or a history of opioid, benzodiazepine or other known drug abuse that may affect sleep.
• Allergic to the research medication.

Sponsors & Collaborators

• Tongji Hospital: lead

MeSH Terms

Interventions

remimazolam; Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: July 31, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07