Improving Perioperative Sleep Disorders

NCT06512155 | Completed Phase 1

• 1 other identifier: Sleep disorders-1
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Pittsburgh Sleep Quality Index score

  On the 30th day after surgery

• Hamilton Anxiety Scale (HAMA)

  Two days before surgery and five days after surgery

• VAS score

  Five days after surgery

• Perioperative opioid consumption

  Immediately after discharge

• Postoperative hospitalization time

  Immediately after discharge

Study Arms (3)

Pregabalin Group

EXPERIMENTAL

The Pregabalin group started taking Pregabalin 75mg bid two days before surgery and Pregabalin 150mg bid from the day before surgery to three days after surgery

Drug: Pregabalin

Zolpidem Group

EXPERIMENTAL

Patients in the zolpidem group took zolpidem 10mg every night from two days before surgery to three days after surgery

Drug: Zolpidem

Control group

NO INTERVENTION

Control group patients do not take any additional medication that affects sleep

Interventions

Pregabalin DRUG

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

Also known as: Pregabalin Capsules (Lerika)

Pregabalin Group

Zolpidem DRUG

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

Also known as: Zolpidem Tartrate Tablets（Sinuosi）

Zolpidem Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old ≤ Age ≤ 65 years old, gender unlimited.
• ASA level I-II.
• Plan to undergo elective total knee arthroplasty, total hip arthroplasty, and spinal vertebral body surgery.

You may not qualify if:

• Patients with preoperative sleep problems.
• Patients refuse to participate in the study.
• The patient has any allergies or contraindications to the drugs used in the study.
• The patient has a history of long-term use of medications such as pregabalin or gabapentin.
• The patient has a history of long-term use of any painkillers or sleeping pills.
• The patient has cognitive impairment and is unable to conduct visits and communication.
• The patient has a history of renal dysfunction or any other serious organ dysfunction.

Sponsors & Collaborators

• Mengchang Yang: lead

Study Sites (1)

Sichuan Provincial People's Hospita

Chengdu, Sichuan, 610000, China

Location

MeSH Terms

Conditions

Sleep Wake Disorders

Interventions

Pregabalin; Zolpidem

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yang Mengchang, Doctor

  Sichuan Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: July 22, 2024
• Study Start: July 2, 2024
• Primary Completion: November 30, 2024
• Study Completion: December 26, 2024
• Last Updated: December 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)