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IRCT20260225068945N1 IRCT 2026-08-15 Khyber Medical University, Pakistan & Green International University, Pakistan “Effect of Different Doses of Intrathecal Magnesium Sulfate (MgSO4) as an Adjunct for the Prevention of Shivering in Patients Undergoing Spinal Anesthesia” DIMS (Dose of Intrathecal MgSo4) “Effect of Different Doses of Intrathecal Magnesium Sulfate (MgSO4) as an Adjunct for the Prevention of Shivering in Patients Undergoing Spinal Anesthesia” 2026-06-25 anticipated 172 Recruiting https://irct.ir/trial/91073 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: N/A, Randomization description: All participants will be given clear information about the study through the clinical trial information sheet. Written consent will be obtained from those who meet the eligibility criteria and agree to participate. Eligible patients will then be randomly assigned to one of three groups using (25 mg, 50 mg, 75 mg) Magnesium Sulfate. Patients in the intervention group will receive spinal anesthesia with 0.5% hyperbaric bupivacaine along with 25mg,50mg,75mg of intrathecal magnesium sulfate diluted in normal saline. Patients in the control group will receive only spinal anesthesia with 0.5% hyperbaric bupivacaine intrathecally. We will record how often shivering occurs during and after surgery and grade its severity using a standard shivering scale. All patients will be closely monitored for blood pressure, heart rate, and any side effects related to intrathecal magnesium sulfate during and after the procedure. • The study drug will be prepared according to group allocation:  Group A: 25 mg Mg SO₄  Group B: 50 mg Mg SO₄  Group C: 75 mg Mg SO₄ • Spinal anesthesia will be administered at L3–L4 or L4–L5 using standard technique with 0.5% hyperbaric bupivacaine plus study drug. • Patients will remain unaware of group allocation (single-blind). A trained independent observer, blinded to group allocation, will record all intraoperative observations. • Standard monitoring (ECG, NIBP, SpO₂) will be applied. Parameters will be recorded at predefined intervals (0, 5, 10, 15, 30, 45, 60 minutes):  Heart rate  Blood pressure  Core temperature  Shivering score (Wrench scale) • Primary outcome: Incidence and severity of shivering will be assessed using the Wrench shivering scale (0–4). • Secondary Outcomes will be recorded:  Onset and duration of sensory block  Duration of motor block  Sedation level (Ramsay scale)  Adverse effects (hypotension, bradycardia, nausea, vomiting) • Management of Adverse Events:  Hypotension will be treated with IV fluids and vasopressors  Bradycardia will be treated with atropine.  The antidote for magnesium sulfate is Calcium gluconate.  All adverse events will be recorded in the pro forma • Data will be recorded on a structured questionnaire. Each patient will be assigned a unique ID number. Data will be entered into SPSS software for analysis, and confidentiality will be maintained throughout, Blinding description: Patients in the intervention group will receive spinal anesthesia with 0.5% hyperbaric bupivacaine along with 25mg, 50mg, 75mg of intrathecal magnesium sulfate diluted in normal saline. Patients in the control group will receive only spinal anesthesia with 0.5% hyperbaric bupivacaine intrathecally. 2 Prevention of shivering in patients undergoing spinal anesthesia. Intervention 1: Control group: Normal Saline as an adjunct with Bupivacaine SP. Intervention 2: Intervention group 1: 25 mg MgSo4 as an adjunct with Bupivacaine SP. Intervention 3: Intervention group 2: 50 mg MgSo4 as an adjunct with Bupivacaine SP. Intervention 4: Intervention group 3: 75 mg MgSO4 as an adjunct with Bupivacaine SP. Yes - There is a plan to make this available What will be shared: Effect of different doses of intrathecal MgSO4 as an adjunct for the prevention of shivering in patients undergoing spinal anesthesia When: After publication for 6 months To whom: Principal Investigator Conditions: N/A Where to obtain: via email muhammadfarman782@gmail.com How to obtain: via email muhammadfarman782@gmail.com Comments:
public Muhammad Farman
Phase 5 Hayatabad
Peshawar Pakistan 25100 +92 311 9148070 muhammadfarman782@gmail.com Khyber Medical University, Peshawar scientific Muhammad Farman
Mohallah Karigaran Pindi Road Togh Bala Tehsil District Kohat
Kohat Pakistan 26010 +92 311 9148070 muhammadfarman782@gmail.com Khyber Medical University Pakistan Age 18-60 years Elective infraumbilical surgeries ASA physical status I–II valid Hemodynamically stable patient Written informed consent provided 18 years 60 years Both Known allergy/hypersensitivity to MgSO4 Patients on Ca channel blockers or sedative medications Baseline hypothermia or fever Neurological or neuromuscular disorders Severe hepatic, renal, cardiac disease Patients with contraindications to spinal anesthesia, such as infection at the injection site and coagulopathy Patients requiring conversion to general anesthesia Pregnant patients (exclude if not specifically studying cesarean cases) O89.5 Other complications of spinal and epidural anesthesia during the puerperium Placebo Treatment - Drugs Treatment - Drugs Treatment - Drugs Control group: Normal Saline as an adjunct with Bupivacaine SP Intervention group 1: 25 mg MgSo4 as an adjunct with Bupivacaine SP Intervention group 2: 50 mg MgSo4 as an adjunct with Bupivacaine SP Intervention group 3: 75 mg MgSO4 as an adjunct with Bupivacaine SP "Incidence of Postoperative Shivering." The shivering that occurs after spinal anesthesia, it will be measured using the wrench shivering scale intraoperatively and 60 mins postoperatively. Timepoint: Intraoperatively and 60 mins postoperatively. Method of measurement: Temperature and physical examination. Onset of sensory block (mins); Time from intrathecal injection to T10 level sensory block. Timepoint: 2-6 hours post spinal. Method of measurement: Bilateral sensation to cold/pinprick. Duration of Sensory Block (mins); Time from maximum sensory block till regression to S1 level. Timepoint: Every 15 minutes after maximum block till S1 level. Method of measurement: Regression of sensory block using cold/pinprick. Duration of motor block (mins); Time from maximum motor block till till recovery of bromage score to "0". Timepoint: Every 15 minutes after spinal anesthesia till motor recovery. Method of measurement: By using modified Bromage scale till Bromage=0. Heart rate changes. Timepoint: Baseline, every 5 min intraoperatively, in recovery. Method of measurement: Measured using continuous ECG monitor. Blood pressure changes. Timepoint: Baseline, every 5 min intraoperatively, in recovery. Method of measurement: Noninvasive, using automated monitor. Incidence of Hypotension,, Blood Pressure more than 20% decrease from baseline. Timepoint: from intrathecal injection till end of surgery. Method of measurement: Blood Pressure more than 20% decrease from baseline. Incidence of bradycardia. Timepoint: From intrathecal injection till end of surgery. Method of measurement: Continuous ECG monitoring, less than 50 beats/min is considered as bradycardia. Postoperative pain intensity. Timepoint: At recovery, 2, 4, 6, 12 and 24 hours postoperatively. Method of measurement: VAS/NRS (0-10). Sedation level. Timepoint: At recovery, 30 min, 1, 2, 4 and 6 hours postoperatively. Method of measurement: Ramsay Sedation Scale (RSS). Incidence of adverse effects. Timepoint: Intraoperatively and up to 24 hours postoperatively. Method of measurement: Clinical assessment and documentation of nausea, vomiting, pruritus, respiratory depression and other adverse events. Patient satisfaction. Timepoint: At 24 hours postoperatively. Method of measurement: Structured patient satisfaction assessment using a predefined satisfaction scale. Khyber Medical University, Pakistan & Green International University, Pakistan Approved 2026-06-29 Ethics Committee of Khyber Medical University Phase-V, Hayatabad Peshawar. Peshawar Khyber PakhtunKhwa Pakistan