A Phase 2 interventional study of Dantrolene and Placebo Oral Tablet in Lumbar Spine Injury, sponsored by Beth Israel Deaconess Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-18.
Sponsored by Beth Israel Deaconess Medical Center · Phase 2, Interventional, and Treatment
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.
57 studies on the registry are indexed under Spinal Injuries; 15 are open to participants now.
This study's enrollment of 116 is above the median of 52 across 31 interventional studies indexed under Spinal Injuries.
Browse Spinal Injuries studies →Beth Israel Deaconess Medical Center is the lead sponsor of 568 studies on the registry; 80 are open to participants now.
Of its 76 completed or terminated interventional studies of FDA-regulated products, 62 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive 25 mg of Dantrolene orally at four different time points: immediately before surgery, as well as at 12, 24 and 36 hours after surgery.
Drug: Dantrolene
Patients will receive a 25 mg of a placebo pill orally at four different time points: immediately before surgery, as well as at 12, 24 and 36 hours after surgery.
Drug: Placebo Oral Tablet
muscle relaxant
Also known as: Dantrium, Dantrolene Sodium
inactive pill
Also known as: placebo
Overall Benefit of Analgesia Score (OBAS)
OBAS scores will be recorded on a scale from 0 (best outcome) to 28 (worst outcome).
Time frame: Measured at 24 hours after surgery
Overall Benefit of Analgesia Score (OBAS)
OBAS scores will be recorded on a scale from 0 (best outcome) to 28 (worst outcome).
Time frame: Measured at 48 hours after surgery
Richmond Agitation Sedation Scale (RASS)
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.
Time frame: Measured at 24 and 48 hours after surgery
Numerical Rating Scale (NRS) for Pain
Pain scores will be recorded on a scale from 0 (best outcome) to 10 (worst outcome).
Time frame: Measured at 24, 48 hours after surgery
Hospital Length of Stay
The length of the patients stay in the hospital will be measured in days
Time frame: Until discharge from the hospital, on average three days
Benzodiazepine Use Postoperatively
The number of patients who receive benzodiazepines after surgery will be recorded.
Time frame: Until discharge from the hospital, on average three days
ICU Mobility Score
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).
Time frame: Measured at 24 and 48 hours after surgery
Oral Morphine Eqivalent (OME) Doses
OME in mg at 24 and 48 hours
Time frame: During postoperative period
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
| Milestone | Dantrolene Group | Placebo Oral Tablet Group |
|---|---|---|
| Started | 58 | 58 |
| Completed | 45 | 52 |
| Not completed | 13 | 6 |
OBAS scores will be recorded on a scale from 0 (best outcome) to 28 (worst outcome).
| OBAS Score | Dantrolene Group | Placebo Oral Tablet Group |
|---|---|---|
| Overall Benefit of Analgesia Score (OBAS) | 4.0 (2 to 6) | 4.0 (2 to 6) |
OBAS scores will be recorded on a scale from 0 (best outcome) to 28 (worst outcome).
| OBAS Score at 48 hours | Dantrolene Group | Placebo Oral Tablet Group |
|---|---|---|
| Overall Benefit of Analgesia Score (OBAS) | 4 (2 to 6) | 4 (2 to 7) |
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.
| Participants | Dantrolene Group | Placebo Oral Tablet Group |
|---|---|---|
| 24 Hours, Score of <0 | 2 | 6 |
| 24 Hours, Score of 0 | 38 | 41 |
| 24 Hours, Score of >0 | 5 | 5 |
| 48 Hours, Score of <0 | 2 | 6 |
| 48 Hours, Score of 0 | 38 | 41 |
| 48 Hours, Score of >0 | 5 | 5 |
Pain scores will be recorded on a scale from 0 (best outcome) to 10 (worst outcome).
| score on a scale | Dantrolene Group | Placebo Oral Tablet Group |
|---|---|---|
| 24 Hours | 6 (4 to 8) | 6 (3.75 to 8) |
| 48 hours | 5 (3.25 to 6.75) | 5 (3 to 7) |
The length of the patients stay in the hospital will be measured in days
| days | Dantrolene Group | Placebo Oral Tablet Group |
|---|---|---|
| Hospital Length of Stay | 4.00 (3 to 5) | 4.50 (3 to 6) |
The number of patients who receive benzodiazepines after surgery will be recorded.
| Participants | Dantrolene Group | Placebo Oral Tablet Group |
|---|---|---|
| Lorazepam | 2 | 4 |
| Diazepam | 22 | 28 |
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).
| score on a scale | Dantrolene Group | Placebo Oral Tablet Group |
|---|---|---|
| ICU Mobility Score at 24 Hours | 7.00 (0 to 9) | 2.00 (0 to 9) |
| ICU Mobility Score at 48 Hours | 8.00 (2.5 to 10) | 5.00 (0 to 9) |
OME in mg at 24 and 48 hours
| mg | Dantrolene Group | Placebo Oral Tablet Group |
|---|---|---|
| OME at 24 Hours | 57.50 (45 to 74.5) | 57.50 (43.62 to 79.06) |
| OME at 48 Hours | 45 (15 to 63.75) | 46.25 (26.25 to 75) |
Collected over Last data collection (48 hours after surgery/baseline). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dantrolene Group | 0/45 (0%) | 0/45 (0%) | 9/45 (20%) |
| Placebo Oral Tablet Group | 0/52 (0%) | 0/52 (0%) | 13/52 (25%) |
| Event | Dantrolene Group | Placebo Oral Tablet Group |
|---|---|---|
| Surgical ComplicationNervous system disorders | 9/45 | 13/52 |
Participants that completed the study
| Age, Continuous(Mean Age in years) | Dantrolene Group | Placebo Oral Tablet Group | Total |
|---|---|---|---|
| Mean | 64 (56 to 69) | 64 (58 to 70) | 64 (56 to 70) |
| Sex: Female, Male(Participants) | Dantrolene Group | Placebo Oral Tablet Group | Total |
|---|---|---|---|
| Female | 16 | 20 | 36 |
| Male | 29 | 32 | 61 |
| Race (NIH/OMB)(Participants) | Dantrolene Group | Placebo Oral Tablet Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 2 | 2 | 4 |
| White | 34 | 44 | 78 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 7 | 5 | 12 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jul 2019 to primary completion in Jun 2024, 58 months.
Results were first posted in Jun 2026, 2 years after primary completion.
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Studies of the drug tested here: Dantrolene
Beth Israel Deaconess Medical Center →