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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

Tracking Information
First Submitted Date  ICMJE September 1, 2022
First Posted Date  ICMJE September 28, 2022
Last Update Posted Date September 29, 2022
Actual Study Start Date  ICMJE September 28, 2022
Estimated Primary Completion Date December 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2022)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Magnesium Use in Reversal of Neuromuscular Block With Sugammadex
Official Title  ICMJE The Effect of Prophylactic Magnesium Use in Pregnant Women on Reversal of Neuromuscular Block With Sugammadex:Evaluation With TOF
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Magnesium Sulfate
  • Pregnancy; Pre-Eclampsia
  • Neuromuscular Blockade
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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
    Intervention: Drug: pregnant women taking magnesium
  • Placebo Comparator: control group
    Pregnant will be operated under general anesthesia
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 26, 2022)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2024
Estimated Primary Completion Date December 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: pregnant
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Meryem Onay 02222392979 ext 5007 dr.meryemonay@hotmail.com
Contact: Ayten Bilir 02222392979 ext 5007 bilirayten@gmail.com
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05558969
Other Study ID Numbers  ICMJE ESOGU 4
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Meryem Onay, Eskisehir Osmangazi University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Eskisehir Osmangazi University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Meryem Onay, asst. prof. Eskisehir Osmangazi University Faculty Of Medicine
PRS Account Eskisehir Osmangazi University
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP