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

Sponsor
Eskisehir Osmangazi University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05558969
Collaborator
(none)
30
1
2
26.1
1.1

Study Details

Study Description

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
  • Drug: pregnant women taking magnesium
  • Drug: Placebo
N/A

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 Design

Study Type:
Interventional
Anticipated 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.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 :
Sep 28, 2022
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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 Names:
  • 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 Names:
  • magnesium level and sugammadex
  • Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    Female
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Eskisehir Osmangazi Universıty Faculty of Medicine Eskisehir Turkey

    Sponsors and Collaborators

    • Eskisehir Osmangazi University

    Investigators

    • Principal Investigator: Meryem Onay, asst. prof., Eskisehir Osmangazi University Faculty Of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Meryem Onay, assistant professor, Eskisehir Osmangazi University
    ClinicalTrials.gov Identifier:
    NCT05558969
    Other Study ID Numbers:
    • ESOGU 4
    First Posted:
    Sep 28, 2022
    Last Update Posted:
    Sep 29, 2022
    Last Verified:
    Sep 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Meryem Onay, assistant professor, Eskisehir Osmangazi University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 29, 2022