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

E

Eskisehir Osmangazi University

Status

Enrolling

Conditions

Magnesium Sulfate
Pregnancy; Pre-Eclampsia
Neuromuscular Blockade

Treatments

Drug: pregnant women taking magnesium
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT05558969
ESOGU 4

Details and patient eligibility

About

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

Full 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.

Enrollment

30 estimated patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

30 participants in 2 patient groups, including a placebo group

pregnant women taking magnesium
Active Comparator group
Description:
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
Treatment:
Drug: pregnant women taking magnesium
control group
Placebo Comparator group
Description:
Pregnant will be operated under general anesthesia
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Central trial contact

Meryem Onay; Ayten Bilir

Data sourced from clinicaltrials.gov

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