Magnesium Sulfate Causing Adverse Effects in Therapeutic UseNCT05427149
The Effect of Intrathecal Magnesium Sulfate on Shivering
A study testing 25 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey) in people with Magnesium Sulfate Causing Adverse Effects in Therapeutic Use and Postoperative Shivering, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
Shivering after spinal anesthesia is a common complication. Mangesium sulfate, which can be used intrathecally, is effective in preventing tremor. But what is the ideal dose? Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Magnesium Sulfate Causing Adverse Effects in Therapeutic Use, Postoperative Shivering, Cesarean Section Complications
- What is being tested?
- 25 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 May 2022to 30 Aug 2022
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Who were scheduled for elective C/S under SA,
- 18-40 years of age
- ASA physical status I-II.
Who cannot join
- Any contraindications to SA,
- preoperative body temperature >38 C,
- allergy to any drug used in the study,
- pre-eclampsia, and eclampsia,
- neuropathy,
- respiratory distress,
Show all 9Show fewer
- coagulopathy, and
- any possible drugs that can change body temperature,
- ASA physical status > II.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Van yuzuncu Yıl University, Dursun Odabas Medical Center
Van, 65080
About this study
Official title: The Effect of Different Doses of Intrathecal Magnesium Sulfate on Shivering After Spinal Anesthesia in Cesarean Sections
Shivering after spinal anesthesia is a common complication. Mangesium sulfate, which can be used intrathecally, is effective in preventing tremor. But what is the ideal dose?
Read the detailed description
Perioperative shivering during cesarean section (CS) under neuraxial anesthesia (NA) is clinically common, but its treatment is often neglected.
When the literature is scanned, perioperative tremors are seen in 55%-60% of patients undergoing neuraxial anesthesia. However, the mechanism of the tremor has not been fully elucidated. Possible factors that can cause tremor can be listed as follows:
- Loss of thermoregulatory vasoconstriction below the block level,
- The displacement of body temperature from the central to the periphery due to vasodilation,
- Increased sweating threshold and decreased peripheral vasoconstriction Perioperative shivering is a complication that needs to be treated because it causes dangerous consequences in patients with low cardiopulmonary reserve due to increased oxygen consumption and impairs patient and surgeon comfort.
Magnesium sulfate is one of the most effective adjuvant drugs with the least side-effect profile in the treatment of tremor after noxial block.
- Conditions
- Magnesium Sulfate Causing Adverse Effects in Therapeutic Use, Postoperative Shivering, Cesarean Section Complications
- Being tested
- 25 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey)
- Keywords
- Bupivacaine, cesarean section, intrathecal magnesium sulfate, shivering, spinal anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
25 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey)Drug
Also called 50 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey), 75 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey), 100 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey)
It will be evaluated whether there is postpinal shivering in the cases.
| Study group | Role | What they receive |
|---|---|---|
| Group C | Active comparator | Patients receiving intrathecal 10 mg hyperbaric bupivacaine (Marcaine® Spinal Heavy %0.5, Sanofi, Kırklareli, Turkey) + 1 mL normal saline (Polifleks %0.9 İzotonik Sodyum Klorür, Polifarma, Ankara, Turkey) Receives: Drug: 25 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey) |
| Group M25 | Active comparator | Patients receiving intrathecal 10 mg hyperbaric bupivacaine (Marcaine® Spinal Heavy %0.5, Sanofi, Kırklareli, Turkey) + 25 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey). MgSO4 diluted to 25mg/mL with normal saline (Polifleks %0.9 İzotonik Sodyum Klorür, Polifarma, Ankara, Turkey). Receives: Drug: 25 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey) |
| Group M50 | Active comparator | Patients receiving intrathecal 10 mg hyperbaric bupivacaine (Marcaine® Spinal Heavy %0.5, Sanofi, Kırklareli, Turkey) + 50 mg/mL MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey). MgSO4 diluted to 50mg/mL with normal saline (Polifleks %0.9 İzotonik Sodyum Klorür, Polifarma, Ankara, Turkey). Receives: Drug: 25 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey) |
| Group M100 | Active comparator | Patients receiving intrathecal 10 mg hyperbaric bupivacaine (Marcaine® Spinal Heavy %0.5, Sanofi, Kırklareli, Turkey) + 100 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey). MgSO4 diluted to 100mg/mL with normal saline (Polifleks %0.9 İzotonik Sodyum Klorür, Polifarma, Ankara, Turkey) Receives: Drug: 25 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of shivering
Intraoperative and postoperative shivering will be evaluated with the shivering test established by Crossley and Mahajan.
flicker tracking; The parameters looked at in this test approved by Crossley and Mahajan are: 0 = no flicker,
- = Piloerection or peripheral vasoconstriction, but no visible shivering,
- = Muscle activity in only 1 muscle group,
- = more muscle activity than 1 muscle group but not generalized
- = Full body shivering
Measured: 3 mounths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start10 May 2022
- Primary completion30 Jun 2022
- Study completion30 Aug 2022
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 Sulfate Causing Adverse Effects in Therapeutic UseStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nureddin YUZKAT, Yuzuncu Yil University
- Investigators
- NUREDDİN YUZKAT, Assoc. prof, Principal investigator, VAN YUZUNCU YIL UNİVERSİTY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05427149
- Sponsor's protocol ID
- Intrathecal magnesium sulfate
- Status last verified
- Sep 2022
- First submitted
- 13 May 2022
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol and statistical analysis plan wil be share other researchers
Publications
Ameta N, Jacob M, Hasnain S, Ramesh G. Comparison of prophylactic use of ketamine, tramadol, and dexmedetomidine for prevention of shivering after spinal anesthesia. J Anaesthesiol Clin Pharmacol. 2018 Jul-Sep;34(3):352-356. doi: 10.4103/joacp.JOACP_211_16.
PubMed 30386019Hoshijima H, Takeuchi R, Kuratani N, Nishizawa S, Denawa Y, Shiga T, Nagasaka H. Incidence of postoperative shivering comparing remifentanil with other opioids: a meta-analysis. J Clin Anesth. 2016 Aug;32:300-12. doi: 10.1016/j.jclinane.2015.08.017. Epub 2015 Oct 1.
PubMed 26432635Jayaraj A, Balachander H, Kuppusamy SK, Arusamy S, Rai Y, Siddiqui N. Comparison of meperidine, tramadol and fentanyl for post-spinal shivering prevention during cesarean delivery: A double-blind randomized controlled trial. J Obstet Gynaecol Res. 2019 Nov;45(11):2202-2208. doi: 10.1111/jog.14106. Epub 2019 Sep 4.
PubMed 31486253
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Doses of Intrathecal Magnesium Sulfate on Shivering After Spinal Anesthesia in Cesarean Sections
- ClinicalTrials.gov ID
- NCT05427149
- Acronym / sponsor ID
- Intrathecal magnesium sulfate
- Conditions
- Magnesium Sulfate Causing Adverse Effects in Therapeutic Use, Postoperative Shivering, Cesarean Section Complications
- Keywords
- Bupivacaine, cesarean section, intrathecal magnesium sulfate, shivering, spinal anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 10 May 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 22 Jun 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.
Shivering after spinal anesthesia is a common complication. Mangesium sulfate, which can be used intrathecally, is effective in preventing tremor. But what is the ideal dose?
Detailed description
Perioperative shivering during cesarean section (CS) under neuraxial anesthesia (NA) is clinically common, but its treatment is often neglected.
When the literature is scanned, perioperative tremors are seen in 55%-60% of patients undergoing neuraxial anesthesia. However, the mechanism of the tremor has not been fully elucidated. Possible factors that can cause tremor can be listed as follows:
- Loss of thermoregulatory vasoconstriction below the block level,
- The displacement of body temperature from the central to the periphery due to vasodilation,
- Increased sweating threshold and decreased peripheral vasoconstriction Perioperative shivering is a complication that needs to be treated because it causes dangerous consequences in patients with low cardiopulmonary reserve due to increased oxygen consumption and impairs patient and surgeon comfort.
Magnesium sulfate is one of the most effective adjuvant drugs with the least side-effect profile in the treatment of tremor after noxial block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group C | Active comparator | Drug: 25 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey)Patients receiving intrathecal 10 mg hyperbaric bupivacaine (Marcaine® Spinal Heavy %0.5, Sanofi, Kırklareli, Turkey) + 1 mL normal saline (Polifleks %0.9 İzotonik Sodyum Klorür, Polifarma, Ankara, Turkey) |
| Group M25 | Active comparator | Drug: 25 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey)Patients receiving intrathecal 10 mg hyperbaric bupivacaine (Marcaine® Spinal Heavy %0.5, Sanofi, Kırklareli, Turkey) + 25 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey). MgSO4 diluted to 25mg/mL with normal saline (Polifleks %0.9 İzotonik Sodyum Klorür, Polifarma, Ankara, Turkey). |
| Group M50 | Active comparator | Drug: 25 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey)Patients receiving intrathecal 10 mg hyperbaric bupivacaine (Marcaine® Spinal Heavy %0.5, Sanofi, Kırklareli, Turkey) + 50 mg/mL MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey). MgSO4 diluted to 50mg/mL with normal saline (Polifleks %0.9 İzotonik Sodyum Klorür, Polifarma, Ankara, Turkey). |
| Group M100 | Active comparator | Drug: 25 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey)Patients receiving intrathecal 10 mg hyperbaric bupivacaine (Marcaine® Spinal Heavy %0.5, Sanofi, Kırklareli, Turkey) + 100 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey). MgSO4 diluted to 100mg/mL with normal saline (Polifleks %0.9 İzotonik Sodyum Klorür, Polifarma, Ankara, Turkey) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Who were scheduled for elective C/S under SA,
- 18-40 years of age
- ASA physical status I-II.
Key exclusion criteria (9 listed)
- Any contraindications to SA,
- preoperative body temperature >38 C,
- allergy to any drug used in the study,
- pre-eclampsia, and eclampsia,
- neuropathy,
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 |
|---|---|---|
| 25 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey)Also: 50 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey), 75 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey), 100 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey)It will be evaluated whether there is postpinal shivering in the cases. | Drug | Group C, Group M100, Group M25, Group M50 |
Primary outcome
Level of shivering
Time frame: 3 mounths
Intraoperative and postoperative shivering will be evaluated with the shivering test established by Crossley and Mahajan. flicker tracking; The parameters looked at in this test approved by Crossley and Mahajan are: 0 = no flicker, 1. = Piloerection or peripheral vasoconstriction, but no visible shivering, 2. = Muscle activity in only 1 muscle group, 3. = more muscle activity than 1 muscle group but not generalized 4. = Full body shivering
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 27 Sep 2022.
- Background: PubMed 30386019Ameta N, Jacob M, Hasnain S, Ramesh G. Comparison of prophylactic use of ketamine, tramadol, and dexmedetomidine for prevention of shivering after spinal anesthesia. J Anaesthesiol Clin Pharmacol. 2018 Jul-Sep;34(3):352-356. doi: 10.4103/joacp.JOACP_211_16.
- Background: PubMed 26432635Hoshijima H, Takeuchi R, Kuratani N, Nishizawa S, Denawa Y, Shiga T, Nagasaka H. Incidence of postoperative shivering comparing remifentanil with other opioids: a meta-analysis. J Clin Anesth. 2016 Aug;32:300-12. doi: 10.1016/j.jclinane.2015.08.017. Epub 2015 Oct 1.
- Background: PubMed 31486253Jayaraj A, Balachander H, Kuppusamy SK, Arusamy S, Rai Y, Siddiqui N. Comparison of meperidine, tramadol and fentanyl for post-spinal shivering prevention during cesarean delivery: A double-blind randomized controlled trial. J Obstet Gynaecol Res. 2019 Nov;45(11):2202-2208. doi: 10.1111/jog.14106. Epub 2019 Sep 4.
- Individual participant dataSharing planned: Yes. Study protocol and statistical analysis plan wil be share other researchers
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.
NUREDDİN YUZKAT, Assoc. prof principal investigator
VAN YUZUNCU YIL UNİVERSİTY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 25 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey) in people with Magnesium Sulfate Causing Adverse Effects in Therapeutic Use and Postoperative Shivering, run by Yuzuncu Yil 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 3 inclusion and 9 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 27 Sep 2022. 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. 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?
Level of shivering (time frame: 3 mounths). 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 NCT05427149, 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 27 Sep 2022; AzTrials last refreshed its copy on 7 Nov 2026.