Improving Perioperative Sleep Disorders
NCT Number: NCT06512155
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Sleep Disorder
Interventions: DRUG: Pregabalin|DRUG: Zolpidem
Sponsor: Mengchang Yang
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 222
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2024-12
Locations: Sichuan Provincial People's Hospital, Chengdu, Sichuan, 610000, China

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.

Primary Outcome Measures: Athens Insomnia Scale, The Athens Insomnia Scale has a minimum score of zero and a maximum score of 24. When the score is greater than or equal to 6, it indicates the presence of sleep disorders, and the higher the score, the more severe the sleep disorders., From the second day of medication to five days after surgery
Secondary Outcome Measures: Pittsburgh Sleep Quality Index score, The total score range of the Pittsburgh Sleep Quality Index is 0-21 points. The higher the score, the worse the sleep quality. An index greater than or equal to 8 points is considered to have a sleep quality issue, On the 30th day after surgery|Hamilton Anxiety Scale (HAMA), A total score of ≥ 29 on the Hamilton Anxiety Scale may indicate severe anxiety 21 points, there must be obvious anxiety; ≥ 14 points, there must be anxiety; Exceeding 7 points may indicate anxiety; If it is less than 7 points, there are no symptoms of anxiety., Two days before surgery and five days after surgery|VAS score, Evaluate patient pain using VAS score five days after surgery, Five days after surgery|Perioperative opioid consumption, Perioperative opioid consumption, converted to morphine equivalent, Immediately after discharge|Postoperative hospitalization time, Postoperative hospitalization time, Immediately after discharge|The incidence of various adverse events, The incidence of various adverse events, including fatigue, drowsiness, dizziness, nausea and vomiting, blurred vision, and other psychological symptoms such as hallucinations, agitation, nightmares, depression, etc, Immediately after discharge|Patient satisfaction survey, The patient satisfaction survey during hospitalization is divided into four levels: very satisfied, relatively satisfied, relatively dissatisfied, and very dissatisfied., Immediately after discharge|Hamilton Depression Scale（HAMD）, Hamilton Depression Scale total score\<7: normal; A total score of 7-17 indicates possible depression; A total score of 17-24 points indicates the presence of depression; Total score\>24: Severe depression。, Two days before surgery and five days after surgery