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

NCT05558969 | Completed

• 1 other identifier: ESOGU 4
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Magnesium Sulfate; Pregnancy; Pre-Eclampsia; Neuromuscular Blockade

Keywords

Preeclampsi; Magnesium sulfate; Sugammadex

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

pregnant women taking magnesium

ACTIVE COMPARATOR

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

control group

PLACEBO COMPARATOR

Pregnant will be operated under general anesthesia

Drug: Placebo

Interventions

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.

Also known as: magnesium level and sugammadex

pregnant women taking magnesium

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.

Also known as: magnesium level and sugammadex

control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: pregnant
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

Study Sites (1)

Eskisehir Osmangazi Universıty Faculty of Medicine

Eskişehir, Eski̇şehi̇r, 26040, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 24608361 BACKGROUND

• 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.

  PMID: 24864211 BACKGROUND

• 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.

  PMID: 26974018 BACKGROUND

MeSH Terms

Conditions

Toxemia

Interventions

Sugammadex

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Study Officials

• Meryem Onay, asst. prof.

  Eskisehir Osmangazi University Faculty Of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: It will be evaluated by another investigator (blind) who does not know in which group the patient is using magnesium sulfate during the intraoperative period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: A total of 30 pregnant women, who are taking magnesium and not taking magnesium, will be included in the study to be taken by cesarean section under general anesthesia.At the end of surgery, whether sugammadex reverses the effect of NMBA will be evaluated. The time up to TOF 0.9 will be recorded.A blood sample will be taken to measure simultaneous calcium and magnesium values.

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: September 28, 2022
• Study Start: September 28, 2022
• Primary Completion: May 20, 2025
• Study Completion: May 26, 2025
• Last Updated: May 28, 2025

Record last verified: 2022-09

Locations

TU (1)