Pharmacokinetic and Pharmacodynamic of Rocuronium

February 25, 2015 updated by: Pontificia Universidad Catolica de Chile

Pharmacokinetic and Pharmacodynamic of Rocuronium Bromide Measured in Adductor Pollicis and Masseter Muscles.

The purpose of this study is characterize the dose-effect relationship of rocuronium bromide at the adductor pollicis and masseter muscles using an pharmacokinetic-pharmacodynamic (PKPD) model. The hypothesis is that masseter muscle has a greater sensitivity to the neuromuscular blockers (rocuronium), faster onset and slower recovery profile than the adductor pollicis muscle.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

10

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

10 ASA I-II patients, aged 18-65 years, scheduled for elective surgery under general anesthesia, were recruited.

Description

Inclusion Criteria:

  • Scheduled for elective surgery under general anesthesia.

Exclusion Criteria:

  • Pregnancy.
  • Body mass index (BMI) >25 kg/m2.
  • Anticipated difficult airway.
  • Surgery associated with great volume loss.
  • Presence of any neuromuscular, hepatic, renal, cardiac or respiratory disease.
  • Previous history of neuromuscular blockade allergy, and/or administration of drugs known to interfere with neuromuscular blockade

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Rocuronium Bromide
Rocuronium 0,3 mg/kg administered in less than five seconds, followed by a saline bolus.
Drug: Rocuronium Bromide
Rocuronium 0,3 mg/kg in less than five seconds, followed by a saline bolus.
Other Names:
  • Rocuronium Bromide Fresenius Kabi

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
strength measuring 2 acceleromyograph. One Placed at the masseter muscle and the other one at the adductor pollicis muscle.
Time Frame: 60 minutes
60 minutes
Measure blood concentrations after administration rocuronium
Time Frame: 120 minutes
120 minutes

Collaborators and Investigators

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

Sponsor

Pontificia Universidad Catolica de Chile

Investigators

  • Study Chair: Luis I Cortinez, MD, Ponticia Universidad Católica

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2013

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

February 12, 2015

First Submitted That Met QC Criteria

February 25, 2015

First Posted (Estimate)

March 3, 2015

Study Record Updates

Last Update Posted (Estimate)

March 3, 2015

Last Update Submitted That Met QC Criteria

February 25, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-003

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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