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 |
|---|---|---|
| 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). |
| 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 24, 48 hours after surgery | Pain scores will be recorded on a scale from 0 (best outcome) to 10 (worst 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 |
| Benzodiazepine Use Postoperatively | Until discharge from the hospital, on average three days | The number of patients who receive benzodiazepines after surgery will be recorded. |
| 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 20 (walking independently without a gait aid; best outcome). |
| Oral Morphine Eqivalent (OME) Doses | During postoperative period | OME in mg at 24 and 48 hours |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRichard J Pollard, MD
Beth Israel Deaconess Medical Center
Participant flow
Recruitment details
Participants were eligible for enrollment if they met all the following criteria: Age 18 to 80 years, inclusive. Scheduled to undergo lumbar spine decompression and/or instrumented fusion involving two or more vertebral levels via a posterior surgical approach under general anesthesia at Beth Israel Deaconess Medical Center. Planned same-day admission or inpatient hospital admission following surgery. Classified as American Society of Anesthesiologists (ASA) physical status I, II, or III
Pre-assignment details
Randomization was performed prior to surgery using a computer-generated randomization scheme prepared by an unblinded statistician and implemented by the research pharmacy. The pharmacy prepared and dispensed identical-appearing study medications to maintain blinding. Participants, clinicians, and all study personnel involved in data collection and outcome assessment were blinded to treatment assignment.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 64 Mean Age in years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 78 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 52 |
| other Total, other adverse events | 9 / 45 | 13 / 52 |
| serious Total, serious adverse events | 0 / 45 | 0 / 52 |
Outcome results
None listed