The Use of Dantrolene to Improve Analgesia in Posterior Lumbar Surgery

NCT ID: NCT03762109

Last Updated: 2024-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-29
• Study Completion Date: 2024-06-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Dantrolene Group

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.

Group Type: EXPERIMENTAL

Dantrolene

Intervention Type: DRUG

muscle relaxant

Placebo Oral Tablet Group

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.

Group Type: PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type: DRUG

inactive pill

Interventions

Dantrolene

muscle relaxant

Intervention Type: DRUG

Placebo Oral Tablet

inactive pill

Intervention Type: DRUG

Other Intervention Names

Dantrium; Dantrolene Sodium; placebo

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Richard J. Pollard

Director, Neurosurgical Anesthesia Fellowship

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard J Pollard, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2018P000799

Identifier Type: -

Identifier Source: org_study_id