Magnesium Sulphate and Rocuronium in Patients Over 60

March 12, 2018 updated by: Pedro Rotava

Effects of Magnesium Sulphate on the Pharmacodynamics of Rocuronium in Patients 60 Years or Older: Randomised and Double-Blind Study

The purpose of this study is to evaluate the effects of MgSO4 administration on the pharmacodynamics of rocuronium in patients with 60 or more years of age.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 20230130
        • Instituto Nacional de Cancer

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

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 60 years or older
  • ASA physical status I-III
  • Scheduled for elective oncologic head and neck surgery

Exclusion Criteria:

  • Severe renal insufficiency (calculated creatinine clearance < 30 ml/min)
  • Pre-operatory serum magnesium values > 2.5 mEq/l
  • Patients receiving medications known to affect neuromuscular function (furosemide, aminoglycoside, anticonvulsivants, calcio channel blocker, litium, azatioprine, cyclofosfamide)

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

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Magnesium sulfate group
In the magnesium group, patients received MgSO4 30 mg/kg in 0.9% physiological saline (total volume 100 ml) intravenously, for 10 min, and then continuous intravenous infusion of MgSO4 at a rate of 1 g/h during the surgical procedure until the maximum of 3 h.
Drug: Magnesium Sulfate
MgSO4 30 mg/kg in 0.9% physiological saline (total volume 100 ml) intravenously, for 10 min, and then continuous intravenous infusion of MgSO4 at a rate of 1 g/h during the surgical procedure until the maximum of 3 h
Placebo Comparator: Control group
Controls received 100 ml of 0.9% physiological saline, for 10 min, and then continuous intravenous infusion of saline at a rate of 33 ml/h during the surgical procedure until the maximum of 3 h.
Drug: Placebo
100 ml of 0.9% physiological saline, for 10 min, and then continuous intravenous infusion of saline at a rate of 33 ml/h during the surgical procedure until the maximum of 3 h

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total recovery time of neuromuscular block (DurTOF0.9)
Time Frame: Within the surgical procedure
Time from the start of injection of rocuronium until TOF ratio 0.9
Within the surgical procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Onset time
Time Frame: Within the surgical procedure
Time from the start of injection of rocuronium until 95% depression of the first twitch (T1) of the TOF
Within the surgical procedure
Clinical duration (Dur25%)
Time Frame: Within the surgical procedure
Time from the start of injection of rocuronium until T1 of the TOF had recovered to 25% of the initial T1 value
Within the surgical procedure
Recovery index (Dur25-75%)
Time Frame: Within the surgical procedure
Time between 25% and 75% recovery of the initial T1 value
Within the surgical procedure
Recovery time (Dur25%TOF0.9)
Time Frame: Within the surgical procedure
Time between 25% recovery of the initial T1 value and a TOF ratio of 0.9
Within the surgical procedure

Collaborators and Investigators

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

Sponsor

Pedro Rotava

Collaborators

Instituto Nacional de Cancer, Brazil

Investigators

  • Principal Investigator: Pedro Rotava, MD, Instituto Nacional de Cancer

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

September 1, 2008

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

February 28, 2013

First Submitted That Met QC Criteria

March 2, 2013

First Posted (Estimate)

March 5, 2013

Study Record Updates

Last Update Posted (Actual)

March 14, 2018

Last Update Submitted That Met QC Criteria

March 12, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MgRoc 60

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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