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Study on dose-effect relationship of general anesthesia drugs on loss of consciousness during anesthesia induction and postoperative sleep quality in patients with sleep disorders

Study on dose-effect relationship of general anesthesia drugs on loss of consciousness during anesthesia induction and postoperative sleep quality in patients with sleep disorders

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069254
Enrollment
Unknown
Registered
2023-03-10
Start date
2022-05-01
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

Sleep disorders

Interventions

Non-sleep disorders group:remimazolam
Sleep disorders group:remimazolam

Sponsors

Changzhou No.2 People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients undergoing elective laparoscopic surgery under tracheal intubation and general anesthesia; 2. Can complete Pittsburgh sleep quality index (PSQI), Simple Mental State Scale (MMSE) score scale; 3. Aged 18-65 years, no gender limit; 4. ASA ?~? grade; 5. 18kg/m^2 < BMI < 30 kg/m^2; 6. Informed consent: voluntary participation in the experiment and informed consent signed by the patient.

Exclusion criteria

Exclusion criteria: 1. Emergency surgery or cardio-cerebrovascular surgery; 2. Patients with severe heart, brain, liver and kidney diseases; 3. Patients with history of cerebral infarction and cerebral hemorrhage; 4. Patients with a history of Alzheimer's disease, Parkinson's disease, delirium; 5. Patients with long-term use of narcotic analgesics, sedatives or non-steroidal anti-inflammatory drugs; 6. Previous history of mental illness; 7. Patients with serious sensory organ defects (such as vision and hearing impairment) or other reasons that can't communicate with visitors normally and affect the evaluation of treatment effect; 8. Patients who quit midway; 9. Participated in clinical trials of other drugs or devices within 3 months prior to the screening period; 10. The investigator considers it inappropriate to participate in this clinical study.

Design outcomes

Primary

MeasureTime frame
Loss of consciousness time;Bispect ral index;Pittsburgh Sleep Quality Index Scores;

Secondary

MeasureTime frame
Blood pressure;Heart rate;Oxygen saturation;

Countries

China

Contacts

Public ContactHu Yimin

Changzhou No.2 People's Hospital

guyueym@njmu.edu.cn+86 138 0903 9818

Outcome results

None listed

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