Post Spinal Anesthesia ShiveringPhase 4NCT07913828
Two Doses of IV Magnesium Sulfate for Prevention of Post-Spinal Shivering
A Phase 4 study testing Magnesium Sulfate 50 mg/kg IV and Magnesium Sulfate 30 mg/kg IV in people with Post Spinal Anesthesia Shivering, run by Suez Canal University at 1 site in Egypt.
Trial summary
The main purpose of the study is to compare the incidence of clinically significant shivering, defined as Grade 3 or 4 on the Crossley-Mahajan shivering scale, within 60 minutes after spinal anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Post Spinal Anesthesia Shivering
- What is being tested?
- Magnesium Sulfate 50 mg/kg IV and Magnesium Sulfate 30 mg/kg IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Nov 2026to 15 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Women aged 18 to 40 years or.
- Scheduled for elective cesarean section under spinal anesthesia.
- Singleton pregnancy at ≥37 weeks of gestation.
- American Society of Anesthesiologists (ASA) physical status I or II.
- Written informed consent to participate in the study.
Who cannot join
- Known allergy or hypersensitivity to magnesium sulfate or pethidine.
- Pre-existing thyroid or metabolic disorders.
- Severe preeclampsia receiving magnesium sulfate therapy.
- Cardiac arrhythmias.
- History of seizures.
- Peripheral neurological disease.
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- Renal disease.
- Neuromuscular disease.
- Maternal fever (>38°C) or hypothermia (<35°C).
- Emergency cesarean section.
- Conversion from spinal to general anesthesia.
- Massive blood transfusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Suez Canal University Hospitals
Ismailia, Ismailia Governorate, 41516
Mohammad Elhossieny Salama, MD, 00201016865861
About this study
Official title: Comparison Between Two Different Doses of Intravenous Magnesium Sulfate for Prevention of Post-Spinal Shivering During Cesarean Section: A Double-Blind Randomized Clinical Trial
The main purpose of the study is to compare the incidence of clinically significant shivering, defined as Grade 3 or 4 on the Crossley-Mahajan shivering scale, within 60 minutes after spinal anesthesia. The study will also compare the severity and onset of shivering, the need for rescue treatment with intravenous pethidine, blood pressure, heart rate, body temperature, sedation, maternal adverse effects, and neonatal outcomes including Apgar scores, need for respiratory support, and admission to the neonatal intensive care unit.
Read the detailed description
Shivering is a common complication of spinal anesthesia and may cause patient discomfort and increase metabolic demands. This study is designed to compare two doses of intravenous magnesium sulfate for prevention of clinically significant post-spinal shivering in women undergoing elective cesarean section under spinal anesthesia.
Eligible participants will be randomly allocated to receive either 50 mg/kg or 30 mg/kg of intravenous magnesium sulfate. The allocated dose will be diluted in 100 mL of normal saline and administered using an infusion pump over 20 minutes, starting immediately after spinal anesthesia. Patients, the anesthesiologist administering the study drug, and outcome observers will be blinded to group allocation.
Patients will receive standardized spinal anesthesia and perioperative monitoring. Shivering will be assessed using the Crossley-Mahajan scale. Clinically significant shivering is defined as Grade 3 or 4. If clinically significant shivering persists for at least 15 minutes, intravenous pethidine 25 mg will be administered as rescue treatment, with a second 25 mg dose permitted if Grade ≥3 shivering persists after reassessment.
The study will evaluate the efficacy of the two magnesium sulfate doses in preventing clinically significant shivering and will assess maternal hemodynamic parameters, temperature, sedation, adverse effects, rescue medication requirements, and neonatal outcomes.
- Conditions
- Post Spinal Anesthesia Shivering
- Being tested
- Magnesium Sulfate 50 mg/kg IV, Magnesium Sulfate 30 mg/kg IV
- Keywords
- post spinal shivering, spinal anesthesia, Cesarean section, Magnesium sulfate, Obstetric anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium Sulfate 50 mg/kg IVDrug
Magnesium sulfate 50 mg/kg was diluted in 100 mL of normal saline and administered intravenously using an infusion pump over 20 minutes, starting immediately after spinal anesthesia.
Magnesium Sulfate 30 mg/kg IVDrug
Magnesium sulfate 30 mg/kg was diluted in 100 mL of normal saline and administered intravenously using an infusion pump over 20 minutes, starting immediately after spinal anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Magnesium Sulfate 50 mg/kg) | Experimental | Not described Receives: Drug: Magnesium Sulfate 50 mg/kg IV |
| Group B (Magnesium Sulfate 30 mg/kg) | Active comparator | Not described Receives: Drug: Magnesium Sulfate 30 mg/kg IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Clinically Significant Post-Spinal Shivering (Crossley-Mahajan Grade ≥3)
Measured: From immediately after spinal anesthesia until 60 minutes after spinal anesthesia
Secondary outcomes (11)
Severity of Post-Spinal Shivering (Crossley-Mahajan Grade 0-4)
Measured: From immediately after spinal anesthesia until 60 minutes after spinal anesthesia
Time to Onset of Post-Spinal Shivering
Measured: From immediately after spinal anesthesia until the first occurrence of shivering, assessed for up to 60 minutes after spinal anesthesia.
Cumulative Dose of Intravenous Pethidine Used as Rescue Treatment for Post-Spinal Shivering
Cumulative dose of intravenous pethidine administered as rescue treatment for clinically significant shivering (Crossley-Mahajan Grade ≥3).
Measured: From the onset of clinically significant shivering until discharge from the recovery room.
Systolic, Diastolic, and Mean Arterial Blood Pressure
Measured: Immediately before spinal anesthesia (baseline), and at 0, 5, 10, 15, 20, 25, 30, 45, and 60 minutes after spinal anesthesia.
Heart rate
Measured: Immediately before spinal anesthesia (baseline), and at 0, 5, 10, 15, 20, 25, 30, 45, and 60 minutes after spinal anesthesia.
Core Body Temperature
Measured: Immediately before spinal anesthesia (baseline), and at 0, 5, 10, 15, 20, 25, 30, 45, and 60 minutes after spinal anesthesia.
Sedation Score Assessed Using the Modified Ramsay Sedation Scale
Measured: Immediately before spinal anesthesia (baseline), and at 0, 5, 10, 15, 20, 25, 30, 45, and 60 minutes after spinal anesthesia.
Apgar Score at 1 and 5 Minutes After Birth
Measured: At 1 and 5 minutes after birth.
Need for Neonatal Respiratory Support
Measured: From birth through 24 hours after birth.
Neonatal Intensive Care Unit (NICU) Admission
Measured: From birth through 24 hours after birth.
Incidence of Maternal Adverse Effects
Incidence of hypotension, bradycardia, respiratory depression, nausea, vomiting, and flushing.
Measured: From initiation of study drug administration through 24 hours after delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start2 Nov 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Spinal Anesthesia ShiveringStudies of the same condition, open and under way.
- More trials run by Suez Canal UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammad Elhossieny Salama, MD, Principal investigator, Faculty of Medicine, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07913828
- Sponsor's protocol ID
- 6170#
- Status last verified
- Sep 2026
- First submitted
- 27 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Two Different Doses of Intravenous Magnesium Sulfate for Prevention of Post-Spinal Shivering During Cesarean Section: A Double-Blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07913828
- Acronym / sponsor ID
- 6170#
- Conditions
- Post Spinal Anesthesia Shivering
- Keywords
- post spinal shivering, spinal anesthesia, Cesarean section, Magnesium sulfate, Obstetric anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 2 Nov 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 3 Nov 2026 (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.
The main purpose of the study is to compare the incidence of clinically significant shivering, defined as Grade 3 or 4 on the Crossley-Mahajan shivering scale, within 60 minutes after spinal anesthesia. The study will also compare the severity and onset of shivering, the need for rescue treatment with intravenous pethidine, blood pressure, heart rate, body temperature, sedation, maternal adverse effects, and neonatal outcomes including Apgar scores, need for respiratory support, and admission to the neonatal intensive care unit.
Detailed description
Shivering is a common complication of spinal anesthesia and may cause patient discomfort and increase metabolic demands. This study is designed to compare two doses of intravenous magnesium sulfate for prevention of clinically significant post-spinal shivering in women undergoing elective cesarean section under spinal anesthesia.
Eligible participants will be randomly allocated to receive either 50 mg/kg or 30 mg/kg of intravenous magnesium sulfate. The allocated dose will be diluted in 100 mL of normal saline and administered using an infusion pump over 20 minutes, starting immediately after spinal anesthesia. Patients, the anesthesiologist administering the study drug, and outcome observers will be blinded to group allocation.
Patients will receive standardized spinal anesthesia and perioperative monitoring. Shivering will be assessed using the Crossley-Mahajan scale. Clinically significant shivering is defined as Grade 3 or 4. If clinically significant shivering persists for at least 15 minutes, intravenous pethidine 25 mg will be administered as rescue treatment, with a second 25 mg dose permitted if Grade ≥3 shivering persists after reassessment.
The study will evaluate the efficacy of the two magnesium sulfate doses in preventing clinically significant shivering and will assess maternal hemodynamic parameters, temperature, sedation, adverse effects, rescue medication requirements, and neonatal outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Magnesium Sulfate 50 mg/kg) | Experimental | Drug: Magnesium Sulfate 50 mg/kg IV |
| Group B (Magnesium Sulfate 30 mg/kg) | Active comparator | Drug: Magnesium Sulfate 30 mg/kg IV |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women aged 18 to 40 years or.
- Scheduled for elective cesarean section under spinal anesthesia.
- Singleton pregnancy at ≥37 weeks of gestation.
- American Society of Anesthesiologists (ASA) physical status I or II.
- Written informed consent to participate in the study.
Key exclusion criteria (12 listed)
- Known allergy or hypersensitivity to magnesium sulfate or pethidine.
- Pre-existing thyroid or metabolic disorders.
- Severe preeclampsia receiving magnesium sulfate therapy.
- Cardiac arrhythmias.
- History of seizures.
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 |
|---|---|---|
| Magnesium Sulfate 50 mg/kg IVMagnesium sulfate 50 mg/kg was diluted in 100 mL of normal saline and administered intravenously using an infusion pump over 20 minutes, starting immediately after spinal anesthesia. | Drug | Group A (Magnesium Sulfate 50 mg/kg) |
| Magnesium Sulfate 30 mg/kg IVMagnesium sulfate 30 mg/kg was diluted in 100 mL of normal saline and administered intravenously using an infusion pump over 20 minutes, starting immediately after spinal anesthesia. | Drug | Group B (Magnesium Sulfate 30 mg/kg) |
Primary outcome
Incidence of Clinically Significant Post-Spinal Shivering (Crossley-Mahajan Grade ≥3)
Time frame: From immediately after spinal anesthesia until 60 minutes after spinal anesthesia
11 secondary outcomes
Severity of Post-Spinal Shivering (Crossley-Mahajan Grade 0-4)
Time frame: From immediately after spinal anesthesia until 60 minutes after spinal anesthesia
Time to Onset of Post-Spinal Shivering
Time frame: From immediately after spinal anesthesia until the first occurrence of shivering, assessed for up to 60 minutes after spinal anesthesia.
Cumulative Dose of Intravenous Pethidine Used as Rescue Treatment for Post-Spinal Shivering
Time frame: From the onset of clinically significant shivering until discharge from the recovery room.
Systolic, Diastolic, and Mean Arterial Blood Pressure
Time frame: Immediately before spinal anesthesia (baseline), and at 0, 5, 10, 15, 20, 25, 30, 45, and 60 minutes after spinal anesthesia.
Heart rate
Time frame: Immediately before spinal anesthesia (baseline), and at 0, 5, 10, 15, 20, 25, 30, 45, and 60 minutes after spinal anesthesia.
Core Body Temperature
Time frame: Immediately before spinal anesthesia (baseline), and at 0, 5, 10, 15, 20, 25, 30, 45, and 60 minutes after spinal anesthesia.
Sedation Score Assessed Using the Modified Ramsay Sedation Scale
Time frame: Immediately before spinal anesthesia (baseline), and at 0, 5, 10, 15, 20, 25, 30, 45, and 60 minutes after spinal anesthesia.
Apgar Score at 1 and 5 Minutes After Birth
Time frame: At 1 and 5 minutes after birth.
Need for Neonatal Respiratory Support
Time frame: From birth through 24 hours after birth.
Neonatal Intensive Care Unit (NICU) Admission
Time frame: From birth through 24 hours after birth.
Incidence of Maternal Adverse Effects
Time frame: From initiation of study drug administration through 24 hours after delivery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Post Spinal Anesthesia Shivering
Not yet recruitingPhase 4
Optimizing the Paracetamol Dose for Prevention of Post-Spinal Shivering in Lower Limb Orthopedic Surgeries
Shivering, Postoperative Shivering
Not yet recruitingPhase 4
Effect of Preoperative Intranasal Dexmedetomidine on Incidence of Intraoperative Shivering in Patients Undergoing Cesarean Section Under Spinal Anesthesia
Shivering, Hypothermia
Not yet recruitingPhase 4
Intravenous Paracetamol Versus Magnesium Sulfate for Control of Shivering Following Spinal Anesthesia in Cesarean Section
Shivering, Post-Spinal Shivering
Not yet recruitingPhase 4
Efficacy of Intravenous Midazolam-Ketamine Combination Versus Placebo for Prevention of Post-Spinal Shivering in Elective Cesarean Section
Shivering, Post-Spinal Shivering
Not yet recruiting
Comparison of Low-Dose Intravenous Ketamine and Tramadol for Prevention of Post-Spinal Anaesthesia Shivering in Orthopedic Surgical Patients
Post-spinal Anesthesia Shivering
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.
Mohammad Elhossieny Salama, MD principal investigator
Faculty of Medicine, Suez Canal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Magnesium Sulfate 50 mg/kg IV and Magnesium Sulfate 30 mg/kg IV in people with Post Spinal Anesthesia Shivering, run by Suez Canal University at 1 site in Egypt.
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 5 inclusion and 12 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: opening soon, as of the sponsor's last update on 3 Nov 2026. 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 Egypt. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammad Elhossieny Salama, MD (00201016865861, MohammadElhossieny88@med.suez.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Clinically Significant Post-Spinal Shivering (Crossley-Mahajan Grade ≥3) (time frame: From immediately after spinal anesthesia until 60 minutes after spinal anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2026.