RecruitingPhase 4NCT05746143

The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion

The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion: A Randomized Control Trial


Sponsor

University of Southern California

Enrollment

140 participants

Start Date

Feb 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate if peri-operative zolpidem for posterior lumbar spinal fusion improves patient reported outcomes following surgery.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria3

  • degenerative lumbar disease
  • age of 18-75
  • undergoing open primary one- to three-level lumbar fusion

Exclusion Criteria7

  • currently use a sleep aid nightly
  • diagnosed with insomnia or sleep apnea
  • history of delirium with opiates or zolpidem
  • allergic to opiates or zolpidem
  • had previous lumbar spine surgery
  • undergoing minimally invasive lumbar fusion,
  • undergoing lumbar fusion for fracture, infection, tumor, or an inflammatory spondyloarthropathy

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Interventions

DRUGZolpidem Tartrate 10 mg

two days preoperatively and five days postoperatively

DRUGPlacebo

two days preoperatively and five days postoperatively


Locations(1)

Keck Medical Center of USC

Los Angeles, California, United States

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NCT05746143


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