Intraoperative Phenylephrine Infusion to Reduce Postoperative Shivering in Lower Segment Caesarean Section

Study Overview
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Brief Summary
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Assessment of whether and how phenylephrine infusion reduces postoperative shivering in spinal anaesthesia.

Detailed Description
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This study aims to evaluate whether phenylephrine infusion can reduce postoperative shivering among patients scheduled for elective lower segment caesarean section under spinal anaesthesia.

Official Title
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Intraoperative Phenylephrine Infusion to Reduce Postoperative Shivering in Lower Segment Caesarean Section

Conditions
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Postoperative Shivering

Intervention / Treatment
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* Drug: Phenylephrine
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: More than 18 years of age American Society of Anesthesiologists (ASA) II patients Patients with singleton pregnancy who are scheduled to undergo elective lower segment caesarean section under spinal anaesthesia Exclusion Criteria: Patients with contraindication to phenylephrine Patients with evidence of fever or infection, or hypothermia preoperatively BMI ≥ 40 Height <150cm

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A (Phenylephrine)<br>Phenylephrine infusion started immediately after administration of spinal block | Drug: Phenylephrine<br>* Phenylephrine infusion 0.3ml/kg/hour (equivalent to 0.5mcg/kg/min, phenylephrine dilution is 100mcg/ml in 20ml syringe)<br>|
| Placebo Comparator: Group B (Saline)<br>Normal saline infusion started immediately after administration of spinal block | Drug: Normal saline<br>* Normal saline infusion 0.3ml/kg/hour (normal saline in 20ml syringe)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence and intensity of shivering | Any presence of shivering intraoperatively is recorded. The intensity of shivering is recorded based on the Bedside Shivering Assessment Scale (BSAS) with a scoring of 0-3 (0 = no shivering, 1 = shivering localised to neck and/or thorax, 2 = shivering involves gross movement of upper extremities, 3 = shivering involves gross movements of the trunk, upper and lower extremities). | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient's core and skin temperature | Patient's core (tympanic membrane) and skin (forehead) temperature is measured using an infrared thermometer. | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phenylephrine, Spinal anaesthesia