Effects of Magnesium Sulphate on Sugammadex Reversal of Rocuronium Induced Blockade in Gynaecology Patients

January 10, 2014 updated by: Zehra Ipek ARSLAN, Kocaeli University

Background: The aim of this prospective study was to evaluate the effect of magnesium on the reversal of rocuronium-induced neuromuscular block by sugammadex.

Methods: Eighty patients, aged 18 to 60 years, American Society of Anesthesiologists I-II, undergoing elective gynecological surgery were enrolled. Anaesthesia was induced with propofol and fentanyl and was maintained with 60% nitrous oxide and Oxygen in sevoflurane. The magnesium group received 50 milligram/kilogram (mg/kg) Magnesium intravenous (iv) as a bolus and 15 mg/kg/hour by continuous infusion until the completion of surgery. The placebo group received the equivalent volume of isotonic saline. For intubation, 0.6 mg/kg rocuronium was administered and 0.1 mg/kg was added when Train of four (TOF) counts reached 1 or more during the procedure. At the end of the surgery at a TOF count of 1, 4 mg/kg sugammadex iv was administered. Patients were observed until a TOF ratio of 0.9 was achieved. Patient-controlled analgesia with intravenous morphine was used postoperatively.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Inclusion criteria:

  • American Society of Anesthesiologists physical status I or II
  • 18-60 years of age
  • undergoing elective gynecological surgery
  • requiring endotracheal intubation

Exclusion criteria:

  • Patients who had body mass index > 35
  • gastroesophageal reflux
  • a history of allergy
  • used medication known to interact with the drugs being used in this trial
  • who experienced expected or unexpected difficulty during intubation or ventilation
  • had neuromuscular disease
  • hepatic or renal insufficiency
  • pregnant
  • were American Society of Anesthesiologists III or IV
  • had a family history of malignant hyperthermia
  • detection if low or high control plasma magnesium levels

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 4

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

  • Turkey
      • Kocaeli, Turkey, 41380
        • Kocaeli University Hospital

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 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • female patients
  • American Society of Anesthesiologists (ASA) physical status I or II
  • 18-60 years of age who were undergoing elective gynecological surgery
  • requiring endotracheal intubation were enrolled in this prospective study.

Exclusion Criteria:

  • Patients who had body mass index > 35
  • gastroesophageal reflux
  • a history of allergy
  • used medication known to interact with the drugs being used in this trial
  • who experienced expected or unexpected difficulty during intubation or ventilation
  • had neuromuscular disease
  • hepatic or renal insufficiency
  • were pregnant
  • had a family history of malignant hyperthermia
  • detection if low or high control plasma magnesium levels

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: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: sugammadex and placebo
sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 placebo: isotonic saline (%0.9 NaCl) 50 mg/kg iv bolus plus 15 mg/kg continuous infusion until the end of surgery
Drug: placebo
Active comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion
Other Names:
  • isotonic saline
  • %0.9 NaCl
Drug: sugammadex
4 mg/kg iv bolus at the end of the surgery
Other Names:
  • bridion
Experimental: sugammadex and magnesium sulphate
sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 magnesium: 50 mg/kg iv bolus plus continuous infusion until the end of surgery
Drug: sugammadex
4 mg/kg iv bolus at the end of the surgery
Other Names:
  • bridion
Drug: Magnesium Sulphate

Experimental :

50 mg/kg bolus plus 15 mg/kg continuous infusion

Other Names:
  • magnesium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
TOF 0.9 Achieving Time
Time Frame: end of the surgery
end of the surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Rocuronium Onset Time
Time Frame: during the surgery
during the surgery
Rocuronium Supplementation
Time Frame: during surgery
during surgery
Postoperative Morphine Consumption
Time Frame: after 12 hour surgery
after 12 hour surgery

Collaborators and Investigators

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

Sponsor

Kocaeli University

Investigators

  • Principal Investigator: Zehra I. ARSLAN, Asst. Prof., Anesthesiology and Reanimation

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, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

October 11, 2013

First Submitted That Met QC Criteria

October 24, 2013

First Posted (Estimate)

October 30, 2013

Study Record Updates

Last Update Posted (Estimate)

February 25, 2014

Last Update Submitted That Met QC Criteria

January 10, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KOU 2012 KAEK 144

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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