Status:
COMPLETED
The Use of Dantrolene to Improve Analgesia in Posterior Lumbar Surgery
Lead Sponsor:
Beth Israel Deaconess Medical Center
Conditions:
Lumbar Spine Injury
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2024
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03762109
Start Date
July 29 2019
End Date
June 1 2024
Last Update
July 11 2024
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215