University gets ok to start trial of Myalgia drug

The Indiana University announced that the Food and Drug Administration had cleared its application to proceed to a clinical trial involving about 300 people.

The researchers will investigate the effect of pretreatment with Roc on succinylcholine myalgias.

Succinylcholine is a medication (depolarizing muscle relaxant) that is used as part of an anesthetic (going to sleep for surgery). This medication can cause significant muscle soreness. Rocuronium is a medication (non-depolarizing muscle relaxant) that some anesthesia providers believe may reduce muscle soreness caused by succinylcholine if given prior, but this has been controversial. Some anesthesiologists pretreat patients with rocuronium before giving patients succinylcholine, and some do not. The purpose of this study is to figure out if pretreatment with rocuronium reduces muscle soreness associated with succinylcholine administration.

After IRB approval from Indiana University Hospital and with written and verbal informed consent from each patient, 300 ASA I, II and III outpatients scheduled for elective Endoscopic Retrograde Cholangiopancreatography (ERCP) under general anesthesia will be enrolled in this randomized-controlled study. The patients and the study personnel performing post-op assessments will be blinded. Anesthesiologists cannot be blinded during this study since they will be required to draw up the study drugs as well as managing the wait time between rocuronium and succinylcholine. Patients are assigned to one of three groups (n = 100 each group). Each patient will undergo a standard IV induction of anesthesia.

The estimated study start day was scheduled for 2 October, 2020.

The planned outcome measure that are the most important for evaluating the effect of the treatment:

1. Presence and severity of myalgias. Prior to leaving the hospital the subject will be asked about the presence of myalgias referencing a severity scale from 0 (no muscle pain) to 4 debilitating muscle pain.

2. Presence and severity of myalgias. The following day the subject will be asked about the presence and severity of muscle pain using the same scale mentioned above and described in detail in the study design section. This interaction with the subject will likely occur over the telephone as ERCP is usually an outpatient procedure.

The Sponsor and recruiting facility is Indiana University, Indianapolis in Indiana, United States.

For more details please follow the link.

https://ichgcp.net/clinical-trials-registry/NCT04581395

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