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The Effect of Preoperative Oral Midazolam on Postoperative Sleep Quality in Anxious Patients

The Effect of Preoperative Oral Midazolam on Postoperative Sleep Quality in Anxious Patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093894
Enrollment
Unknown
Registered
2024-12-13
Start date
2024-12-13
Completion date
Unknown
Last updated
2024-12-16

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

Conditions

Postoperative sleep disorders

Interventions

Experimental group:Preoperative oral administration of midazolam oral solution 0.16mg/kg
Control group:Oral placebo 10% glucose 5ml

Sponsors

Affiliated Hospital of Guizhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Patients undergoing gynecological laparoscopic surgery under elective general anesthesia; 2.Age range: 18-65 years old; 3.ASA levels I-III; 4.Preoperative anxiety PAS score greater than or equal to 8 points 5.Patients voluntarily participate in the study

Exclusion criteria

Exclusion criteria: 1. Individuals with a history of severe heart, brain, lung, liver, kidney, and metabolic diseases; 2. Patients with respiratory diseases such as asthma and chronic obstructive pulmonary disease in the past; 3.History of acute respiratory inflammation within 2 weeks without cure; 4.Long term use of analgesics, sedatives, and antipsychotic drugs; 5.Individuals with neurological and muscular disorders, as well as mental illnesses; 6.Individuals known to be allergic to emulsions, benzodiazepines, and opioids; 7.Predicting those who may experience or have experienced difficult airways; 8.Those who are uncooperative and unable to communicate; 9.Patients currently participating in other clinical trials; 10.Patients who have been diagnosed with diabetes.

Design outcomes

Primary

MeasureTime frame
Postoperative night sleep monitoring results on the day and the second day;Athens Insomnia Scale;

Secondary

MeasureTime frame
Restoration Quality Assessment (Restoration Quality Scale QOR-15);Anxiety score (PAS score) and Ramsay sedation score 10 minutes before anesthesia;; The dosage of sedative and analgesic drugs during surgery;Wake-up time; The time from patient discontinuation of medication to extubation;Pain Scale (VAS) score;Patient satisfaction score;;Postoperative adverse reactions or complications; Nausea, vomiting, drowsiness, delirium, dizziness, other adverse reactions, etc; ;Postoperative hospitalization time.;

Countries

China

Contacts

Public ContactXiaohua Zou

Affiliated Hospital of Guizhou Medical University

294676396@qq.com+86 155 0851 6196

Outcome results

None listed

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