Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pharmacokinetic and Pharmacodynamic of Rocuronium

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02376595
Recruitment Status : Completed
First Posted : March 3, 2015
Last Update Posted : March 3, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Neuromuscular Blockade Drug: Rocuronium Bromide

Layout table for study information
Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pharmacokinetic and Pharmacodynamic of Rocuronium Bromide Measured in Adductor Pollicis and Masseter Muscles.
Study Start Date : March 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


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 Name: Rocuronium Bromide Fresenius Kabi




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

Biospecimen Retention:   Samples Without DNA
Plasma samples.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02376595


Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Investigators
Layout table for investigator information
Study Chair: Luis I Cortinez, MD Ponticia Universidad Católica
Publications:

Layout table for additonal information
Responsible Party: Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT02376595    
Other Study ID Numbers: 12-003
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: March 3, 2015
Last Verified: February 2015
Keywords provided by Pontificia Universidad Catolica de Chile:
Rocuronium
Pharmacokinetics
Pharmacodynamics
Additional relevant MeSH terms:
Layout table for MeSH terms
Bromides
Rocuronium
Anticonvulsants
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs