The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion
NCT ID: NCT05746143
Last Updated: 2024-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
140 participants
INTERVENTIONAL
2022-02-01
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Zolpidem
Zolpidem Tartrate 10 mg
two days preoperatively and five days postoperatively
Placebo
Placebo
two days preoperatively and five days postoperatively
Interventions
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Zolpidem Tartrate 10 mg
two days preoperatively and five days postoperatively
Placebo
two days preoperatively and five days postoperatively
Eligibility Criteria
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Inclusion Criteria
* age of 18-75
* undergoing open primary one- to three-level lumbar fusion
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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University of Southern California
OTHER
Responsible Party
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Raymond Hah
Assistant Professor of Clinical Orthopaedic Surgery
Locations
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Keck Medical Center of USC
Los Angeles, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HS-22-00529
Identifier Type: -
Identifier Source: org_study_id
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