The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion

NCT ID: NCT05746143

Last Updated: 2024-06-25

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2027-12-31

Brief Summary

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

Detailed Description

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Patients who are undergoing one- to three-level spinal fusion for degenerative lumbar disease will be recruited. They will be randomized to either receive zolpidem or placebo two days preoperatively and five days postoperatively.

Conditions

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Spine Fusion Lumbar Spine Degeneration Pain, Postoperative Lumbar Spine Spondylosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Zolpidem

Group Type EXPERIMENTAL

Zolpidem Tartrate 10 mg

Intervention Type DRUG

two days preoperatively and five days postoperatively

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

two days preoperatively and five days postoperatively

Interventions

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Zolpidem Tartrate 10 mg

two days preoperatively and five days postoperatively

Intervention Type DRUG

Placebo

two days preoperatively and five days postoperatively

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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Raymond Hah

Assistant Professor of Clinical Orthopaedic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Keck Medical Center of USC

Los Angeles, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Pui Yan, MS

Role: CONTACT

323-442-6984

Facility Contacts

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Pui Yan, MS

Role: primary

323-442-6984

Other Identifiers

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HS-22-00529

Identifier Type: -

Identifier Source: org_study_id

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