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

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: Completed
• Conditions: Neuromuscular Blockade; Magnesium Sulfate; Pregnancy; Pre-Eclampsia
• Intervention / Treatment: Drug: pregnant women taking magnesium; Drug: Placebo

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 (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Eski̇şehi̇r
    • Eskisehir, Eski̇şehi̇r, Turkey, 26040
      • Eskisehir Osmangazi Universıty Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

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	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

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

Publications and helpful links

General Publications

• Czarnetzki C, Tassonyi E, Lysakowski C, Elia N, Tramer MR. Efficacy of sugammadex for the reversal of moderate and deep rocuronium-induced neuromuscular block in patients pretreated with intravenous magnesium: a randomized controlled trial. Anesthesiology. 2014 Jul;121(1):59-67. doi: 10.1097/ALN.0000000000000204.
• Chattopadhyay S, Das A, Pahari S. Fetomaternal outcome in severe preeclamptic women undergoing emergency cesarean section under either general or spinal anesthesia. J Pregnancy. 2014;2014:325098. doi: 10.1155/2014/325098. Epub 2014 Apr 17.
• Stourac P, Adamus M, Seidlova D, Pavlik T, Janku P, Krikava I, Mrozek Z, Prochazka M, Klucka J, Stoudek R, Bartikova I, Kosinova M, Harazim H, Robotkova H, Hejduk K, Hodicka Z, Kirchnerova M, Francakova J, Obare Pyszkova L, Hlozkova J, Sevcik P. Low-Dose or High-Dose Rocuronium Reversed with Neostigmine or Sugammadex for Cesarean Delivery Anesthesia: A Randomized Controlled Noninferiority Trial of Time to Tracheal Intubation and Extubation. Anesth Analg. 2016 May;122(5):1536-45. doi: 10.1213/ANE.0000000000001197.

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2022
• Primary Completion (Actual): May 20, 2025
• Study Completion (Actual): May 26, 2025

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): May 28, 2025
• Last Update Submitted That Met QC Criteria: May 26, 2025
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Sugammadex; Magnesium sulfate; Preeclampsi
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Hypertension, Pregnancy-Induced; Eclampsia; Pre-Eclampsia
• 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