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

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ClinicalTrials.gov Identifier: NCT05558969
Recruitment Status : Recruiting
First Posted : September 28, 2022
Last Update Posted : September 29, 2022
Sponsor:
Information provided by (Responsible Party):
Meryem Onay, 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

Condition or disease Intervention/treatment Phase
Magnesium Sulfate Pregnancy; Pre-Eclampsia Neuromuscular Blockade Drug: pregnant women taking magnesium Drug: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Double (Participant, 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.
Primary Purpose: Treatment
Official Title: The Effect of Prophylactic Magnesium Use in Pregnant Women on Reversal of Neuromuscular Block With Sugammadex:Evaluation With TOF
Actual Study Start Date : September 28, 2022
Estimated Primary Completion Date : December 1, 2024
Estimated Study Completion Date : December 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Arm Intervention/treatment
Active Comparator: 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
Drug: 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. 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.
Other Name: magnesium level and sugammadex

Placebo Comparator: control group
Pregnant will be operated under general anesthesia
Drug: Placebo
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.
Other Name: magnesium level and sugammadex




Primary Outcome Measures :
  1. Recovery time [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   pregnant
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05558969


Contacts
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Contact: Meryem Onay 02222392979 ext 5007 dr.meryemonay@hotmail.com
Contact: Ayten Bilir 02222392979 ext 5007 bilirayten@gmail.com

Locations
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Turkey
Eskisehir Osmangazi Universıty Faculty of Medicine Recruiting
Eskisehir, Turkey
Contact: Meryem Onay         
Sponsors and Collaborators
Eskisehir Osmangazi University
Investigators
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Principal Investigator: Meryem Onay, asst. prof. Eskisehir Osmangazi University Faculty Of Medicine
Publications:
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Responsible Party: Meryem Onay, assistant professor, Eskisehir Osmangazi University
ClinicalTrials.gov Identifier: NCT05558969    
Other Study ID Numbers: ESOGU 4
First Posted: September 28, 2022    Key Record Dates
Last Update Posted: September 29, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Meryem Onay, Eskisehir Osmangazi University:
Preeclampsi
Magnesium sulfate
Sugammadex
Additional relevant MeSH terms:
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Eclampsia
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications