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Completed

NCT Number: NCT05558969

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Eskisehir Osmangazi Universıty Faculty of Medicine

Eskişehir, Eski̇şehi̇r, 26040, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pregnant women taking magnesium

Drug

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

Drug

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Eskisehir Osmangazi University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 28, 2022
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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