Pharmacokinetic and Pharmacodynamic of Rocuronium

Completed

• Conditions: Neuromuscular Blockade
• Interventions: Drug: Rocuronium Bromide

• Registration Number: NCT02376595
• Lead Sponsor: Pontificia Universidad Catolica de Chile

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2013-11
• Study Completion: 2015-01
• Status Verified: 2015-02
• Study First Submitted: 2015-02-12
• Study First Submitted QC: 2015-02-25
• Last Update Submitted: 2015-02-25
• Study First Posted: 2015-03-03
• Last Update Posted: 2015-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rocuronium Bromide	Rocuronium Bromide	Rocuronium 0,3 mg/kg administered in less than five seconds, followed by a saline bolus.

Primary Outcome Measures

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