Clinical trial NCT03762109: The Use of Dantrolene to Improve Analgesia in Posterior Lumbar Surgery
Official title: The Use of Dantrolene to Improve Analgesia in Posterior Lumbar Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lumbar Spine Injury
Keywords: Surgery
Dantrolene
Anesthesia
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2018-12-03
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Scale (RASS) scores in patients undergoing lumbar fusion.


Eligibility 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

Primary outcomes:
measure: Overall Benefit of Analgesia Score (OBAS)
timeFrame: Measured at 24 hours after surgery
Secondary outcomes:
measure: Overall Benefit of Analgesia Score (OBAS)
timeFrame: Measured at 48 hours after surgery
measure: Richmond Agitation Sedation Scale (RASS)
timeFrame: Measured at 24 and 48 hours after surgery
measure: Numerical Rating Scale (NRS) for Pain
timeFrame: Measured at 0, 1, 2, 3, 24, 48 hours after surgery
measure: ICU Length of Stay
timeFrame: Until discharge from the hospital, on average 24 hours
measure: Hospital length of stay
timeFrame: Until discharge from the hospital, on average three days
measure: Benzodiazepine use postoperatively
timeFrame: Until discharge from the hospital, on average three days
measure: Morphine Equivalent Dose
timeFrame: Duration of the patient's stay in the hospital, on average three days
measure: ICU Mobility Score
timeFrame: Measured at 24 and 48 hours after surgery
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Richard J Pollard, MD
role: PRINCIPAL_INVESTIGATOR
References: