The Dose-Response Relationship of Rocuronium in Patients Taking Pyridostigmine

July 15, 2016 updated by: Shashi Bhatt, MD

The Dose-response Relationship of Rocuronium in Patients Taking Pyridostigmine Preoperatively Compared With Age and Sex Matched Controls

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).

Study Overview

Status

Withdrawn

Conditions

Detailed Description

No subjects enrolled. No data collected.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Toledo, Ohio, United States, 43614
        • University of Toledo, Health Science Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
pyridostigmine
administration of rocuronium to determine its potency.
control arm (no pyridostigmine)
determination of potency of rocuronium in patients not taking pyridostigmine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose of the muscle relaxant rocuronium that will lead to 50% decrease in the force of the evoked muscle contraction in patients taking pyridostigmine.
Time Frame: 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shashi Bhatt, MD

Investigators

  • Principal Investigator: Shashi Bhatt, MD, University of Toledo Health Science Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

May 21, 2014

First Submitted That Met QC Criteria

June 5, 2014

First Posted (Estimate)

June 6, 2014

Study Record Updates

Last Update Posted (Estimate)

July 19, 2016

Last Update Submitted That Met QC Criteria

July 15, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pyridostigmine

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No data collected.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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