Clinical trial NCT05558969: The Effect of Magnesium Use in Reversal of Neuromuscular Block With Sugammadex
Official title: The Effect of Prophylactic Magnesium Use in Pregnant Women on Reversal of Neuromuscular Block With Sugammadex:Evaluation With TOF
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Magnesium Sulfate
Pregnancy; Pre-Eclampsia
Neuromuscular Blockade
Keywords: Preeclampsi
Magnesium sulfate
Sugammadex
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2022-09-28
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recovery time
timeFrame: at end of surgery (Postoperative 2 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Eskisehir
country: Turkey
facility: Eskisehir Osmangazi Universıty Faculty of Medicine
state: Eski̇şehi̇r
Study officials:
affiliation: Eskisehir Osmangazi University Faculty Of Medicine
name: Meryem Onay, asst. prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.