Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
NCT Number: NCT03762109
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.
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Notify Me18 year–80 year
All sexes
Interventional
Phase 2
Boston, Massachusetts, 02215, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
muscle relaxant
Other names: Dantrium, Dantrolene Sodium
inactive pill
Other names: placebo
Time frame: Measured at 24 hours after surgery
OBAS scores will be recorded on a scale from 0 (best outcome) to 28 (worst outcome).
Time frame: Measured at 48 hours after surgery
OBAS scores will be recorded on a scale from 0 (best outcome) to 28 (worst outcome).
Time frame: 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.
Time frame: Measured at 24, 48 hours after surgery
Pain scores will be recorded on a scale from 0 (best outcome) to 10 (worst outcome).
Time frame: Until discharge from the hospital, on average three days
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
The number of patients who receive benzodiazepines after surgery will be recorded.
Time frame: 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).
Time frame: During postoperative period
OME in mg at 24 and 48 hours
Beth Israel Deaconess Medical Center
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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