Effects of Magnesium Sulfate on Onset and Duration of Low Dose Rocuronium

April 15, 2016 updated by: Seoul National University Hospital
This study aims to evaluate effects of magnesium sulfate on onset and duration of low dose rocuronium, intubation condition and surgical condition.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

84

Phase

  • Not Applicable

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

    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
        • Seoul National Univ. Bundang Hospita

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-75 yr American Society of Anesthesiologists physical status 1 or 2, BMI of 20-24.9 kg/m2 scheduled for elective laryngeal microsurgery

Exclusion Criteria:

  • severe respiratory or cardiac disease hepatic or renal function impairment neuromuscular disease on medications affecting neuromuscular function with known allergy to the drugs

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: standard dose rocuronium group
pretreatment of saline 100ml and rocuronium 0.6 mg/kg
Patients in each group received 0.9% normal saline (total volume 100 ml) alone intravenously for 5 min before induction of anesthesia
Active Comparator: low dose rocuronium group
pretreatment of saline 100ml and rocuronium 0.45 mg/kg
Patients in each group received 0.9% normal saline (total volume 100 ml) alone intravenously for 5 min before induction of anesthesia
Active Comparator: low dose rocuronium plus magnesium group
pretreatment of magnesium sulfate 30 mg/kg and rocuronium 0.45 mg/kg
Patients in each group received the magnesium sulfate 30 mg/kg for 2 min in 0.9% normal saline (total volume 100 ml) intravenously for 5 min before induction of anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
onset time of rocuronium
Time Frame: from injection of rocuronium to T1 suppression more than 95% up to 10 minutes
from injection of rocuronium to T1 suppression more than 95% up to 10 minutes
from injection of rocuronium to T1 suppression more than 95% up to 10 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
maximal suppression time and duration of rocuronium
Time Frame: time from the injection of rocuronium to T1 maximal suppression time and reversal of T1 25% up to 1 hours
time from the injection of rocuronium to T1 maximal suppression time and reversal of T1 25% up to 1 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
intubation condition
Time Frame: intubation condition during induction of anesthesia up to 10 minutes
We scored intubation condition on the basis of 4 items, laryngoscopy, vocal cord position, moving of limbs, and coughing.
intubation condition during induction of anesthesia up to 10 minutes
surgical condition
Time Frame: intraoperative surgical condition
to score a surgical condition according to 7 point likers scale
intraoperative surgical condition
postoperative sore throat
Time Frame: postoperative sore throat up to 4 hours
postoperative sore throat up to 4 hours

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Sang Hwan Do, Seoul National Univ. Bundang Hospital

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

October 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

December 11, 2013

First Submitted That Met QC Criteria

March 26, 2014

First Posted (Estimate)

March 31, 2014

Study Record Updates

Last Update Posted (Estimate)

April 18, 2016

Last Update Submitted That Met QC Criteria

April 15, 2016

Last Verified

July 1, 2015

More Information

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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