The Use of Dantrolene to Improve Analgesia in Posterior Lumbar Surgery

• Status: Recruiting
• Trial end date: 2021-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beth Israel Deaconess Medical Center
• Treatments: Dantrolene

Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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