The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05746143
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Southern California
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Spine Fusion, Lumbar Spine Degeneration, Pain, Postoperative, Lumbar Spine Spondylosis

Additional Details

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.

Arms & Interventions

Arms

Experimental: Zolpidem

Placebo Comparator: Placebo

Interventions

Drug: - Zolpidem Tartrate 10 mg

two days preoperatively and five days postoperatively

Drug: - Placebo

two days preoperatively and five days postoperatively

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Keck Medical Center of USC, Los Angeles, California

Status

Recruiting

Address

Keck Medical Center of USC

Los Angeles, California, 90033

Site Contact

Pui Yan, MS

[email protected]

323-442-6984

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