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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05558969
Enrollment
30
Registered
2022-09-28
Start date
2022-09-28
Completion date
2025-05-26
Last updated
2025-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Magnesium Sulfate, Neuromuscular Blockade, Pregnancy; Pre-Eclampsia

Keywords

Preeclampsi, Magnesium sulfate, Sugammadex

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.

Interventions

DRUGpregnant 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.

DRUGPlacebo

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.

Sponsors

Eskisehir Osmangazi University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Recovery timeat end of surgery (Postoperative 2 hours)TOF 0.9 Achieving Time and evaluate the relationship between blood magnesium and calcium level with sugammadex effect.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026