The Use of Dantrolene to Improve Analgesia in Posterior Lumbar Surgery
Completed · Phase 2 · Has a placebo group
Conditions studied: Lumbar Spine Injury
In brief
The purpose of this study is to determine whether administration of a non-centrally acting muscle relaxants will improve the Overall Benefit of Analgesia Score (OBAS), and Richmond Agitation Sedation Scale (RASS) scores in patients undergoing lumbar fusion.
Key facts
- Study ID
- NCT03762109
- Run by
- Beth Israel Deaconess Medical Center
- People needed
- 116
- Starts
- 2019-07-29
- Expected to finish
- 2024-06-01
- Last updated by the study team
- 2026-06-18
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 18 - 80 years of age (inclusive)
- Presenting to the study hospital for lumbar decompression and/or fusion (instrumented fusion of the lumbar spine < 4 levels) under general anesthesia, and scheduled for same-day admission or in-patient admission
- American Society of Anesthesiologists (ASA) Category 1, 2 or 3
You may not qualify if…
- Known allergy to Dantrolene, morphine or other opioids, benzodiazepines that causes a reaction of hives, anaphylaxis, shock, unconsciousness/fainting, rashes/blisters, irregular heartbeat, fever, swelling, shortness of breath, wheezing, serum sickness, drug induced anemia, drug reaction with eosinophilia, and systemic symptoms, or nephritis
- Oxygen saturation < 94%
- Patient being treated with any of the following medications:Non-dihydropyridine Calcium Channel Blockers including verapamil, Estrogen therapy
- Current or past medical history of any of the following: hepatic impairment (including history of transplant), renal impairment or chronic renal disease (including history of transplant), chronic alcohol abuse, chronic respiratory disease (i.e. chronic hypoxia or hypercapnia, COPD)
- Recent history of aspiration (within the last 3 months)
- Patients with any history of neuromuscular dysfunction
- History of obstructive sleep apnea
- Weight > 140 kg
- Currently pregnant
- Actively breastfeeding
- Inability to provide written informed consent
Where it is running
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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