“Effect of Different Doses of Intrathecal Magnesium Sulfate (MgSO4) as an Adjunct for the Prevention of Shivering in Patients Undergoing Spinal Anesthesia”

Determining the effect of different doses of intrathecal magnesium sulfate (MgSO4) as an adjunct to prevent shivering in patients undergoing spinal anesthesia

A single-center, four-arm, parallel-group, blinded, randomized controlled trial involving 172 participants.

The trial will be conducted at Bacha Khan Medical Complex, Swabi, Pakistan. Eligible patients undergoing elective surgery under spinal anesthesia will be randomly allocated to one of four groups. Participants and outcome assessors will be blinded to group allocation. The assigned intervention will be administered according to the study protocol. Standard perioperative monitoring and postoperative follow-up will be performed.

1. Inclusion criteria: Age 18-60 years Elective infraumbilical surgeries Hemodynamically stable patient. ASA physical status I–II valid. Written informed consent provided 2. Exclusion criteria: 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)

Group A will receive 25 mg intrathecal MgSO₄, Group B will receive 50 mg, and Group C will receive 75 mg as an adjunct to spinal anesthesia.

Incidence and severity of shivering Adverse effects: Hypotension, Bradycardia, Nausea/vomiting: Sedation level (Ramsay Sedation Scale) Core body temperature Hemodynamic parameters: HR,BP Duration of motor block Duration of sensory block Onset of sensory block: patient satisfaction

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.

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.

Effect of different doses of intrathecal MgSO4 as an adjunct for the prevention of shivering in patients undergoing spinal anesthesia

After publication for 6 months

Principal Investigator

N/A

via email muhammadfarman782@gmail.com

via email muhammadfarman782@gmail.com