A Phase 4 interventional study of Magnesium Sulfate 50 mg/kg IV and Magnesium Sulfate 30 mg/kg IV in Post Spinal Anesthesia Shivering, sponsored by Suez Canal University. Not yet recruiting at 1 site in Egypt. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Suez Canal University · Phase 4, Interventional, and Prevention
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.
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.
Suez Canal University is the lead sponsor of 164 studies on the registry; 38 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Magnesium Sulfate 50 mg/kg IV
Drug: Magnesium Sulfate 30 mg/kg IV
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 was diluted in 100 mL of normal saline and administered intravenously using an infusion pump over 20 minutes, starting immediately after spinal anesthesia.
Incidence of Clinically Significant Post-Spinal Shivering (Crossley-Mahajan Grade ≥3)
Time frame: From immediately after spinal anesthesia until 60 minutes after spinal anesthesia
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
Cumulative dose of intravenous pethidine administered as rescue treatment for clinically significant shivering (Crossley-Mahajan Grade ≥3).
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
Incidence of hypotension, bradycardia, respiratory depression, nausea, vomiting, and flushing.
Time frame: From initiation of study drug administration through 24 hours after delivery.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Dec 2026, 0 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.