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COMPLETED
NCT07801742
PHASE4

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

Sponsor: Sanatorio Allende

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

54

Start Date

2025-08-05

Completion Date

2026-06-09

Last Updated

2026-09-03

Healthy Volunteers

No

Interventions

DRUG

Zolpidem 10 mg tablets

Zolpidem 10 mg was administered orally once nightly for 14 consecutive nights following total knee arthroplasty.

DRUG

Avocado-soybean unsaponifiables 300 mg

Avocado-soybean unsaponifiables (Prontal) 300 mg were administered orally once nightly for 14 consecutive nights following total knee arthroplasty.

Locations (1)

Sanatorio Allende

Córdoba, Córdoba Province, Argentina