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Clinical study on improving sleep quality of gynecological patients with midazolam before operation

Clinical study on improving sleep quality of gynecological patients with midazolam before operation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113252
Enrollment
Unknown
Registered
2025-11-26
Start date
2025-03-12
Completion date
Unknown
Last updated
2025-12-01

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

Conditions

Postoperative sleep quality

Interventions

Experimental group:Administer midazolam (0.04 mL/kg) upon entering the operating room, followed by normal saline (0.04 mL/kg) before anesthesia induction.
Control Group:Administer normal saline (0.04 mL/kg) upon entering the operating room, followed by midazolam (0.04 mL/kg) before anesthesia induction.

Sponsors

Affiliated Hospital of Yan 'an University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
No minimum to 65 Years

Inclusion criteria

Inclusion criteria: 1)Age less than 65 years; 2)American Society of Anesthesiologists (ASA) physical status classification I-III; 3)Patients scheduled for elective gynecological surgery under general anesthesia; 4)Estimated waiting time in the operating room >= 20 minutes.

Exclusion criteria

Exclusion criteria: 1)Patients with preoperative delirium, dementia, or other psychiatric disorders; 2)Patients taking sleep medications or psychotropic drugs preoperatively; 3)Patients with a history of allergy to benzodiazepines; 4)Patients currently participating in other clinical trials; 5)Patients who refuse to sign the informed consent form

Design outcomes

Primary

MeasureTime frame
Total sleep duration;Sleep efficiency;Deep Sleep Duration;

Secondary

MeasureTime frame
Leeds Sleep Scale score;Pittsburgh Sleep Quality Index;Amsterdam preoperativeanxiety and information scale;Observer's Assessment of Alertness/Sedation Scale;Incidence of postoperative delirium;Incidence of postoperative nausea and vomiting;Length of Hospital Stay;Incidence of intraoperative hypothermia;Postoperative VAS pain score;Post-operative opioid use;Sleep latency;The proportion of deep sleep;Light sleep duration;Rem duration;The number of awakenings after falling asleep;Duration of wakefulness after falling asleep;

Countries

China

Contacts

Public ContactZhang Erfei

Affiliated Hospital of Yan 'an University

1849027105@qq.com+86 138 9117 0975

Outcome results

None listed

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