Magnesium SulfateNCT05558969
The Effect of Magnesium Use in Reversal of Neuromuscular Block With Sugammadex
A study testing pregnant women taking magnesium in people with Magnesium Sulfate and Pregnancy; Pre-Eclampsia, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Magnesium Sulfate, Pregnancy; Pre-Eclampsia, Neuromuscular Blockade
- What is being tested?
- pregnant women taking magnesium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Sep 2022to 26 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Eclampsia,
- chronic hypertension,
- connective tissue disorder,
- muscle disease, neurological problems,
- thyroid dysfunction,
- kidney disease, heart disease,
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eskisehir Osmangazi Universıty Faculty of Medicine
Eskişehir, Eski̇şehi̇r, 26040
About this study
Official title: The Effect of Prophylactic Magnesium Use in Pregnant Women on Reversal of Neuromuscular Block With Sugammadex:Evaluation With TOF
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
Read the 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.
- Being tested
- pregnant women taking magnesium, Placebo
- Keywords
- Preeclampsi, Magnesium sulfate, Sugammadex
- Medical subject headings
- Toxemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pregnant women taking magnesiumDrug
Also called magnesium level and sugammadex
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.
PlaceboDrug
Also called magnesium level and sugammadex
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.
| Study group | Role | What they receive |
|---|---|---|
| pregnant women taking magnesium | Active comparator | 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 Receives: Drug: pregnant women taking magnesium |
| control group | Placebo comparator | Pregnant will be operated under general anesthesia Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery time
TOF 0.9 Achieving Time and evaluate the relationship between blood magnesium and calcium level with sugammadex effect.
Measured: at end of surgery (Postoperative 2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start28 Sep 2022
- Primary completion20 May 2025
- Study completion26 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Magnesium SulfateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meryem Onay, Eskisehir Osmangazi University
- Investigators
- Meryem Onay, asst. prof., Principal investigator, Eskisehir Osmangazi University Faculty Of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05558969
- Sponsor's protocol ID
- ESOGU 4
- Status last verified
- Sep 2022
- First submitted
- 1 Sep 2022
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 24608361Chattopadhyay 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.
PubMed 24864211Stourac 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.
PubMed 26974018
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Prophylactic Magnesium Use in Pregnant Women on Reversal of Neuromuscular Block With Sugammadex:Evaluation With TOF
- ClinicalTrials.gov ID
- NCT05558969
- Acronym / sponsor ID
- ESOGU 4
- Keywords
- Preeclampsi, Magnesium sulfate, Sugammadex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 28 Sep 2022 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 26 May 2025 (actual)
- First posted
- 28 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| pregnant women taking magnesium | Active comparator | Drug: pregnant women taking magnesiumThe 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 |
| control group | Placebo comparator | Drug: PlaceboPregnant will be operated under general anesthesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (11 listed)
- Eclampsia,
- chronic hypertension,
- connective tissue disorder,
- muscle disease, neurological problems,
- thyroid dysfunction,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pregnant women taking magnesiumAlso: magnesium level and sugammadexThe 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. | Drug | pregnant women taking magnesium |
| PlaceboAlso: magnesium level and sugammadexPregnant 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. | Drug | control group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Background: PubMed 24608361Czarnetzki 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.
- Background: PubMed 24864211Chattopadhyay 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.
- Background: PubMed 26974018Stourac 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meryem Onay, asst. prof. principal investigator
Eskisehir Osmangazi University Faculty Of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pregnant women taking magnesium in people with Magnesium Sulfate and Pregnancy; Pre-Eclampsia, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery time (time frame: at end of surgery (Postoperative 2 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05558969, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.