drugset / Trial / NCT06512155

Improving Perioperative Sleep Disorders

NCT06512155

Phase 1 Completed 215 enrolled Mengchang Yang
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Pregabalin Small molecule 150 mg
Subject Zolpidem Small molecule 10 mg

Indications