The Dose-Response Relationship of Rocuronium in Patients Taking Pyridostigmine

Muscle Relaxants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02157545
• Other study ID #: Pyridostigmine
• Status: Withdrawn
• Phase: Phase 4
• First received: May 21, 2014
• Last updated: July 15, 2016
• Start date: March 2014
• Est. completion date: May 2016

Study information

• Verified date: July 2016
• Source: University of Toledo Health Science Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

Description:

No subjects enrolled. No data collected.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Muscle Hypotonia
• Muscle Relaxants

Locations

Country	Name	City	State
United States	University of Toledo, Health Science Campus	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Shashi Bhatt, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No