The Use of Dantrolene to Improve Analgesia in Posterior Lumbar Surgery

NCT03762109 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: 2018P000799
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Spine Injury

Keywords

Surgery; Dantrolene; Anesthesia

Outcome Measures

Primary Outcomes (1)

• Overall Benefit of Analgesia Score (OBAS)

  OBAS scores will be recorded on a scale from 0 (best outcome) to 28 (worst outcome).

  Measured at 24 hours after surgery

Secondary Outcomes (8)

• Overall Benefit of Analgesia Score (OBAS)

  Measured at 48 hours after surgery

• Richmond Agitation Sedation Scale (RASS)

  Measured at 24 and 48 hours after surgery

• Numerical Rating Scale (NRS) for Pain

  Measured at 0, 1, 2, 3, 24, 48 hours after surgery

• ICU Length of Stay

  Until discharge from the hospital, on average 24 hours

• Hospital length of stay

  Until discharge from the hospital, on average three days

Study Arms (2)

Dantrolene Group

EXPERIMENTAL

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

Placebo Oral Tablet Group

PLACEBO COMPARATOR

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

Interventions

Dantrolene DRUG

muscle relaxant

Also known as: Dantrium, Dantrolene Sodium

Dantrolene Group

Placebo Oral Tablet DRUG

inactive pill

Also known as: placebo

Placebo Oral Tablet Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Spinal Injuries

Interventions

Dantrolene

Condition Hierarchy (Ancestors)

Back Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Hydantoins; Imidazolidines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Richard J Pollard, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Neurosurgical Anesthesia Fellowship

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: December 3, 2018
• Study Start: July 29, 2019
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)