The Dose-Response Relationship of Rocuronium in Patients Taking Pyridostigmine

NCT02157545 | Withdrawn

• 1 other identifier: Pyridostigmine
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Pyridostigmine is a medication that is used in certain heart rate and blood pressure conditions. This medication, as a side effect, is known to also cause changes in the junction between a nerve and muscle. The changes caused at the nerve muscle junction by pyridostigmine could alter the effect of muscle relaxants (a medication used during surgery and anesthesia). The investigators are conducting this study to see whether patients taking pyridostigmine are more or less sensitive to rocuronium (a muscle relaxing medication used during surgery).

Conditions

Muscle Relaxants

Keywords

muscle relaxants; pyridostigmine; pharmacodynamics; potency

Outcome Measures

Primary Outcomes (1)

• Dose of the muscle relaxant rocuronium that will lead to 50% decrease in the force of the evoked muscle contraction in patients taking pyridostigmine.

  Rocuronium used to produce muscle weakness or paralysis during surgery. Its potency is measured as ED50, the dose necessary to cause a 50% reduction in the force of evoked muscle contraction. We intend to determine this measure of potency (ED50 for rocuronium) in patients taking pyridostigmine and compare it with control subjects.

  12 months

Study Arms (2)

pyridostigmine

administration of rocuronium to determine its potency.

control arm (no pyridostigmine)

determination of potency of rocuronium in patients not taking pyridostigmine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects taking pyridostigmine for any reason who are scheduled for surgery under general anesthia.

You may qualify if:

• Patients who take pyridostigmine for any reason or those who are matched by age, sex and weight to subjects taking pyridostigmine
• Patients who will be administered rocuronium during elective procedures as standard clinical care.

You may not qualify if:

• Allergy to rocuronium
• Known neuromuscular disorder, patients suffering from myasthenia gravis
• Subjects taking medications known to impact neuromuscular transmission (ex. gentamicin).

Sponsors & Collaborators

• Shashi Bhatt, MD: lead

Study Sites (1)

University of Toledo, Health Science Campus

Toledo, Ohio, 43614, United States

Location

MeSH Terms

Conditions

Muscle Hypotonia

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Shashi Bhatt, MD

  University of Toledo Health Science Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 21, 2014
• First Posted: June 6, 2014
• Study Start: March 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: July 19, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)