The Effect of Magnesium Use in Reversal of Neuromuscular Block With Sugammadex

September 28, 2022 updated by: Meryem Onay, Eskisehir Osmangazi University

The Effect of Prophylactic Magnesium Use in Pregnant Women on Reversal of Neuromuscular Block With Sugammadex:Evaluation With TOF

Magnesium therapy used for seizure prophylaxis in patients with preeclampsia. Magnesium has been shown to prolong the effect of nondepolarizing neuromuscular blocking agents (NMBA) and neostigmine used to reverse the effect of NMBA in general anesthesia . In this study, the investigators aimed to evaluate time from sugammadex injection to Train-of-four ratio 0.9 who receieved magnesium therapy in reversing the effect of neuromuscular blocking agent during the recovery period and the relationship between magnesium level and duration of action of sugammadex

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Rapid-onset and short-acting agents should be preferred in induction, and full induction doses should be applied since they do not receive premedication and increased volume of distribution. Rapid serial induction and intubation should be performed in pregnancies greater than 20 weeks due to the risk of aspiration. Magnesium potentiates and prolongs the effect of nondepolarizing neuromuscular blocking agents. It is recommended that the TOF value be between 0 and 2 for adequate muscle relaxation in cesarean section anesthesia. In anesthesia induction; thiopental 3-6mg/kg, rocuronium 1mg/kg, and fentanyl 1mcg/kg and dormicum 2mg will administered after the baby birth. Sevoflurane 2-3% and 50% oxygen + 50% air are used for maintenance. If TOF is 0, sugammadex 4mg/kg will be administered to reverse the effect of the muscle relaxant.A blood sample will be taken to measure simultaneous calcium and magnesium values. Patients with a TOF ≥0.9 (gold standard for extubation) or patients will be clinically evaluated and the decision to extubate will be made.

Study Type

Interventional

Enrollment (Anticipated)

30

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 Contact

Study Contact Backup

Study Locations

  • Turkey
      • Eskisehir, Turkey
        • Recruiting
        • Eskisehir Osmangazi Universıty Faculty of Medicine
        • Contact:
          • Meryem Onay

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

Female

Description

Inclusion Criteria:

  • Pregnant women who are scheduled for cesarean section under general anesthesia (pregnant women who do not use magnesium) and who use magnesium for prophylaxis in preeclampsia.

Exclusion Criteria:

  • Eclampsia,
  • chronic hypertension,
  • connective tissue disorder,
  • muscle disease, neurological problems,
  • thyroid dysfunction,
  • kidney disease, heart disease,
  • patients with severe allergic reaction to the agents to be used,
  • sepsis,
  • hypovolemia, abruptio placenta, placenta previa,
  • conditions that will prolong the effect of muscle relaxants (drug use ),
  • pregnant women who did not want to be included in the study

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: pregnant women taking magnesium
The patient group who received magnesium as a 4-6 g loading and 2-3 g/h maintenance dose to prevent convulsions in preeclampsia. Pregnant will be operated under general anesthesia
Drug: pregnant women taking magnesium
The patient group who received magnesium as a 4-6 g loading and 2-3 g/h maintenance dose to prevent convulsions in preeclampsia. Pregnant will be operated under general anesthesia. Sugammadex 4mg/kg will be administered when TOF 0 response is seen at the end of surgery. The time from TOF 0 to TOF 0.9 will be recorded. Magnesium and calcium levels in the blood will be studied.
Other Names:
  • magnesium level and sugammadex
PLACEBO_COMPARATOR: control group
Pregnant will be operated under general anesthesia
Drug: Placebo
Pregnant women who do not receive magnesium therapy and who will be operated under general anesthesia. Sugammadex 4mg/kg will be administered when TOF 0 response is seen at the end of surgery. The time from TOF 0 to TOF 0.9 will be recorded. Magnesium and calcium levels in the blood will be studied.
Other Names:
  • magnesium level and sugammadex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recovery time
Time Frame: at end of surgery (Postoperative 2 hours)
TOF 0.9 Achieving Time and evaluate the relationship between blood magnesium and calcium level with sugammadex effect.
at end of surgery (Postoperative 2 hours)

Collaborators and Investigators

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

Sponsor

Eskisehir Osmangazi University

Investigators

  • Principal Investigator: Meryem Onay, asst. prof., Eskisehir Osmangazi University Faculty of Medicine

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)

September 28, 2022

Primary Completion (ANTICIPATED)

December 1, 2024

Study Completion (ANTICIPATED)

December 1, 2024

Study Registration Dates

First Submitted

September 1, 2022

First Submitted That Met QC Criteria

September 26, 2022

First Posted (ACTUAL)

September 28, 2022

Study Record Updates

Last Update Posted (ACTUAL)

September 29, 2022

Last Update Submitted That Met QC Criteria

September 28, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESOGU 4

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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