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Completed NCT07801742

EFFECT OF ZOLPIDEM ON SLEEP QUALITY AND OPIOID CONSUMPTION FOLLOWING PRIMARY TOTAL KNEE ARTHROPLASTY: A PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL

Conditions: Postoperative Pain Management in Total Knee Arthroplasty

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 54
Sponsor: Sanatorio Allende

Location: Sanatorio Allende Córdoba Córdoba Province

Summary

This clinical trial evaluated whether zolpidem could improve sleep quality and postoperative recovery in patients undergoing total joint arthroplasty. Participants were randomly assigned to receive either zolpidem 10 mg or a placebo for 14 nights, beginning after hospital discharge. Neither the participants nor their physicians knew which treatment was assigned. The study assessed sleep quality and duration, postoperative pain, use of pain medications, functional recovery, satisfaction, and adverse events. The study hypothesis was that improving sleep with zolpidem would lead to better sleep and potentially improve pain control and recovery after surgery compared with placebo.

Eligibility Criteria

Inclusion Criteria: * Age ≥18 years. * Undergoing primary total knee arthroplasty (TKA). * Ability to understand the study procedures. * Ability to provide written informed consent. * Ability to complete the postoperative questionnaires. Exclusion Criteria: * History of hypersensitivity to zolpidem or other hypnotic agents. * Revision total knee arthroplasty. * Arthroplasty performed for fracture. * Preoperative use of sleep medications. * Obstructive sleep apnea. * Severe respiratory insufficiency. * Severe hepatic disease. * Cognitive impairment preventing reliable assessment.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07801742). StuddyBuddy aggregates publicly available trial information.