Clinical trial

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

Name

HS-22-00529

Description

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

Trial arms

Trial start

2022-02-01

Estimated PCD

2023-12-31

Trial end

2025-12-31

Status

Recruiting

Treatment

Zolpidem Tartrate 10 mg

two days preoperatively and five days postoperatively

Arms:

Zolpidem

Placebo

two days preoperatively and five days postoperatively

Arms:

Placebo

Size

140

Primary endpoint

Visual analog scale (VAS)

Postoperative day five

Eligibility 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 140, 'type': 'ESTIMATED'}}

Updated at

2023-02-27

1 organization

1 product

1 drug

5 indications

Organization

University of Southern California

Product

Zolpidem Tartrate

Indication

Spinal Fusion