Magnesium Sulfate Effect Following the Reversal of Neuromuscular Blockade Induced by Rocuronium With Sugammadex

February 8, 2018 updated by: Paulo Alipio Germano Filho, Universidade Federal do Rio de Janeiro
The aim of this study is to evaluate the treatment effect of magnesium sulfate on the T4 / T1 ratio after reversal with sugammadex deep or moderate neuromuscular blockade induced by rocuronium.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Sugammadex is a novel neuromuscular blocking reversal agent. Its mechanism of action is the encapsulation of rocuronium and vecuronium molecules. Numerous studies show a potential role of magnesium in reducing anesthetic requirements, sympathetic response to surgical trauma, antinociceptive action and neuroprotective effects. However, its use is limited because magnesium potentiates non-depolarizing neuromuscular blocking agents.

Primary outcome: evaluating the effect of treatment with magnesium sulfate the T4 / T1 ratio after reversal with sugammadex deep and moderate neuromuscular blockade induced by rocuronium.

Secondary outcome: evaluate the occurrence of severe respiratory events, the incidence of residual neuromuscular block in the post-anesthetic recovery room, evolution of T1 high, and postoperative pain.

Study Type

Interventional

Enrollment (Actual)

60

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

  • Brazil
    • RJ
      • Rio de Janeiro, RJ, Brazil, 22271042
        • Hospital Federal de Bonsucesso

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA physical status 1 or 2
  • weight BMI 18.5-24.9
  • otorhinolaryngological surgeries

Exclusion Criteria:

  • refusal to participate in the study;
  • pregnancy or suspected pregnancy;
  • neuromuscular diseases, renal or hepatic impairment;
  • hepatic dysfunction;
  • story or predictors of difficult airway;
  • hypermagnesemia (Mg> 2.5 mEq / L);
  • hypomagnesemia (Mg <1.7 mEq / L);
  • furosemide, aminoglycosides, aminophylline azathioprine; cyclophosphamide, anti-inflammatory and magnesium;
  • allergy to drugs used in the study;
  • participants from other clinical studies.

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Magnesium Sulfate
  1. After anaesthesia induction and calibration of neuromuscular monitoring (acceleromyography) 0,6 mg/kg of rocuronium is given intravenously.
  2. After recovery of the neuromuscular block to a posttetanic count of 2 (deep neuromuscular block) or reappearance of 2 twitches of the train of four (moderate neuromuscular block), 4 mg/kg (deep neuromuscular block) or 2 mg/kg (moderate neuromuscular block) of sugammadex are given intravenously.
  3. INTERVENTION: After 90% of baseline T4 / T1, are injected intravenously magnesium sulfate 60 mg/kg over 10 minutes (100 mL solution).
Drug: Magnesium Sulfate
After 90% of baseline T4 / T1, are injected intravenously magnesium sulfate 60 mg/kg over 10 minutes (100 mL solution).
Other Names:
  • magnesium sulphate
Placebo Comparator: Saline Solution
  1. After anaesthesia induction and calibration of neuromuscular monitoring (acceleromyography) 0,6 mg/kg of rocuronium is given intravenously.
  2. After recovery of the neuromuscular block to a posttetanic count of 2 (deep neuromuscular block) or reappearance of 2 twitches of the train of four (moderate neuromuscular block), 4 mg/kg (deep neuromuscular block) or 2 mg/kg (moderate neuromuscular block) of sugammadex are given intravenously.
  3. INTERVENTION: After 90% of baseline T4 / T1, are injected intravenously 100 mL saline solution over 10 minutes.
Drug: Saline
After 90% of baseline T4 / T1, are injected intravenously saline solution over 10 minutes (100 mL solution).
Other Names:
  • NaCl 0,9%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the effect of treatment with magnesium sulfate the T4 / T1 ratio .
Time Frame: 3 hours
The T4 / T1 ratio after reversal with sugammadex deep and moderate neuromuscular blockade induced by rocuronium.Clinical tests and contraction of the adductor pollicis muscle in response to ulnar nerve train-of-four (TOF) stimulation was acceleromyographically quantified using a TOF-Watch SX.
3 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Record the possible serious respiratory events in the post-anesthetic recovery room
Time Frame: 1 hour after the end of surgery
Obstruction of the upper airway that requires intervention; mild to moderate hypoxemia - lower saturation between 90% -93%, with no improvement after request to deep breathing or tactile stimulation; severe hypoxemia - saturation less than 90%, with no improvement after request to deep breathing or tactile stimulation; signs of increased work of breathing - more than 20 breaths per minute and use of accessory muscles; inability to breathe deeply when requested; via musculature of signs of weakness air higher, as speech disability; reintubation in the post anesthetic recovery room; clinical evidence or suspicion of bronchial aspiration after extubation (gastric contents oropharyngeal or tracheal tube accompanied by hypoxemia).
1 hour after the end of surgery
Evaluate the occurrence of any residual neuromuscular block in the post anesthetic recovery room
Time Frame: 1 hour after the end of surgery
Clinical tests and contraction of the adductor pollicis muscle in response to ulnar nerve train-of-four (TOF) stimulation was acceleromyographically quantified using a TOF-Watch SX.
1 hour after the end of surgery
Record the evolution of the height of the first response (T1)
Time Frame: 1 hour after the end of surgery
Clinical tests and contraction of the adductor pollicis muscle in response to ulnar nerve train-of-four (TOF) stimulation was acceleromyographically quantified using a TOF-Watch SX.
1 hour after the end of surgery
Record the possible occurrence of severe respiratory complications every 24 hours
Time Frame: 72 hours max
Obstruction of the upper airway that requires intervention; mild to moderate hypoxemia - lower saturation between 90% -93%, with no improvement after request to deep breathing or tactile stimulation; severe hypoxemia - saturation less than 90%, with no improvement after request to deep breathing or tactile stimulation; signs of increased work of breathing - more than 20 breaths per minute and use of accessory muscles; inability to breathe deeply when requested; via musculature of signs of weakness air higher, as speech disability; reintubation in the post anesthetic recovery room; clinical evidence or suspicion of bronchial aspiration after extubation (gastric contents oropharyngeal or tracheal tube accompanied by hypoxemia).
72 hours max
Evaluate postoperative pain
Time Frame: 72 hours
Use of visual analogue pain scale (0-10) questionnaire
72 hours

Collaborators and Investigators

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

Sponsor

Universidade Federal do Rio de Janeiro

Investigators

  • Study Director: Nubia V Figueiredo, PhD, Universidade Federal do Rio de Janeiro
  • Principal Investigator: Paulo A Germano Filho, MSc, Hospital Federal de Bonsucesso
  • Study Director: Ismar L Cavalcanti, PhD, Universidade Federal Fluminense

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 (Actual)

October 1, 2016

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

July 25, 2016

First Submitted That Met QC Criteria

October 10, 2016

First Posted (Estimate)

October 13, 2016

Study Record Updates

Last Update Posted (Actual)

February 12, 2018

Last Update Submitted That Met QC Criteria

February 8, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAGF02MG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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