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Improving Perioperative Sleep Disorders

NCT06512155 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 215

Last updated 2024-12-30

No results posted yet for this study

Summary

In today's day of increasing surgical volume, perioperative sleep disorders are an issue that cannot be ignored. They are an important component of perioperative brain protection. Physiologically and psychologically, sleep disorders cause serious damage to patients. The application of pregabalin aims to improve the sleep quality of hand surgery patients, and its anti anxiety effect can also alleviate preoperative anxiety. At the same time, its analgesic mechanism is different from that of opioid drugs, which is also conducive to reducing the use of opioid drugs. Therefore, we propose the following hypothesis: for orthopedic patients with high incidence of postoperative pain and sleep disorders, the use of pregabalin will improve the perioperative sleep quality of such patients.To test the above hypothesis, our research group plans to conduct this prospective, randomized, positive control study.

Conditions

  • Sleep Disorder

Interventions

DRUG

Pregabalin

Start taking 75mg bid of pregabalin two days before surgery, and take 150mg bid of pregabalin from one day before surgery to three days after surgery

DRUG

Zolpidem

Take zolpidem 10mg qn from two days before surgery to three days after surgery

Sponsors & Collaborators

  • Mengchang Yang

    lead OTHER

Principal Investigators

  • Yang Mengchang, Doctor · Sichuan Provincial People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-02
Primary Completion
2024-11-30
Completion
2024-12-26

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06512155 on ClinicalTrials.gov