Clinical trial NCT02376595: Pharmacokinetic and Pharmacodynamic of Rocuronium
Official title: Pharmacokinetic and Pharmacodynamic of Rocuronium Bromide Measured in Adductor Pollicis and Masseter Muscles.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuromuscular Blockade
Keywords: Rocuronium
Pharmacokinetics
Pharmacodynamics
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
First posted: 2015-03-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: strength measuring 2 acceleromyograph. One Placed at the masseter muscle and the other one at the adductor pollicis muscle.
timeFrame: 60 minutes
measure: Measure blood concentrations after administration rocuronium
timeFrame: 120 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ponticia Universidad Católica
name: Luis I Cortinez, MD
role: STUDY_CHAIR
References:
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