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

Not Applicable

Recruiting

• Conditions: Magnesium Sulfate; Pregnancy; Pre-Eclampsia; Neuromuscular Blockade
• Interventions: Drug: pregnant women taking magnesium; Drug: Placebo

• Registration Number: NCT05558969
• Lead Sponsor: Eskisehir Osmangazi University

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

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 Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-01
• Study First Submitted QC: 2022-09-26
• Study Start: 2022-09-28
• Study First Posted: 2022-09-28
• Last Update Submitted: 2022-09-28
• Last Update Posted: 2022-09-29
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pregnant women taking magnesium	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
control group	Placebo	Pregnant will be operated under general anesthesia

Primary Outcome Measures

Name	Time	Method
Recovery time	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.

Trial Locations

Locations (1)

Eskisehir Osmangazi Universıty Faculty of Medicine; 🇹🇷 Eskisehir, Turkey