The Effect of Magnesium Use in Reversal of Neuromuscular Block With Sugammadex
Primary Purpose
Magnesium Sulfate, Pregnancy; Pre-Eclampsia, Neuromuscular Blockade
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
pregnant women taking magnesium
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Magnesium Sulfate focused on measuring Preeclampsi, Magnesium sulfate, Sugammadex
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
Sites / Locations
- Eskisehir Osmangazi Universıty Faculty of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
pregnant women taking magnesium
control group
Arm 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
Pregnant will be operated under general anesthesia
Outcomes
Primary Outcome Measures
Recovery time
TOF 0.9 Achieving Time and evaluate the relationship between blood magnesium and calcium level with sugammadex effect.
Secondary Outcome Measures
Full Information
NCT ID
NCT05558969
First Posted
September 1, 2022
Last Updated
September 28, 2022
Sponsor
Eskisehir Osmangazi University
1. Study Identification
Unique Protocol Identification Number
NCT05558969
Brief Title
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
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 28, 2022 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eskisehir Osmangazi University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Magnesium Sulfate, Pregnancy; Pre-Eclampsia, Neuromuscular Blockade
Keywords
Preeclampsi, Magnesium sulfate, Sugammadex
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
pregnant women taking magnesium
Arm Type
Active Comparator
Arm 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
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
Pregnant will be operated under general anesthesia
Intervention Type
Drug
Intervention Name(s)
pregnant women taking magnesium
Other Intervention Name(s)
magnesium level and sugammadex
Intervention 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. 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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
magnesium level and sugammadex
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recovery time
Description
TOF 0.9 Achieving Time and evaluate the relationship between blood magnesium and calcium level with sugammadex effect.
Time Frame
at end of surgery (Postoperative 2 hours)
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnant
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meryem Onay
Phone
02222392979
Ext
5007
Email
dr.meryemonay@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ayten Bilir
Phone
02222392979
Ext
5007
Email
bilirayten@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meryem Onay, asst. prof.
Organizational Affiliation
Eskisehir Osmangazi University Faculty Of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eskisehir Osmangazi Universıty Faculty of Medicine
City
Eskisehir
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meryem Onay
12. IPD Sharing Statement
Citations:
PubMed Identifier
24608361
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.
Results Reference
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PubMed Identifier
24864211
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.
Results Reference
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PubMed Identifier
26974018
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.
Results Reference
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The Effect of Magnesium Use in Reversal of Neuromuscular Block With Sugammadex
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