Lumbar Spine Injury
Conditions
Keywords
Surgery, Dantrolene, Anesthesia
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.
Interventions
DRUGDantrolene
muscle relaxant
DRUGPlacebo Oral Tablet
inactive pill
Sponsors
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Benefit of Analgesia Score (OBAS) | Measured at 24 hours after surgery | OBAS scores will be recorded on a scale from 0 (best outcome) to 28 (worst outcome). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Richmond Agitation Sedation Scale (RASS) | Measured at 24 and 48 hours after surgery | The Richmond Agitation and Sedation Scale (RASS) is a validated and reliable method to assess patients' level of sedation in the intensive care unit. Scores range from +4 (combative) to -5 (unarousable). A score of 0 (alert and calm) is considered the best outcome. |
| Numerical Rating Scale (NRS) for Pain | Measured at 0, 1, 2, 3, 24, 48 hours after surgery | Pain scores will be recorded on a scale from 0 (best outcome) to 10 (worst outcome). |
| ICU Length of Stay | Until discharge from the hospital, on average 24 hours | The length of the patients stay in the ICU will be measured in hours |
| Overall Benefit of Analgesia Score (OBAS) | Measured at 48 hours after surgery | OBAS scores will be recorded on a scale from 0 (best outcome) to 28 (worst outcome). |
| Benzodiazepine use postoperatively | Until discharge from the hospital, on average three days | The number of patients who receive benzodiazepines after surgery will be recorded. |
| Morphine Equivalent Dose | Duration of the patient's stay in the hospital, on average three days | The postoperative analgesia requirement of narcotic medications during the patients recovery will be measured in morphine equivalent dose (miligrams) |
| ICU Mobility Score | Measured at 24 and 48 hours after surgery | The patients ability to move will be recorded on a scale from 0 (nothing, lying in bed; worst outcome) to 10 (walking independently without a gait aid; best outcome). |
| Hospital length of stay | Until discharge from the hospital, on average three days | The length of the patients stay in the hospital will be measured in days |
Countries
United States
Outcome results
None listed