Effectiveness of Continuous Phenylephrine in Preventing Shivering After Spinal Anesthesia in Cesarean Section

Universitas Indonesia108 enrolled

Overview

This study aims to evaluate the effectiveness of continuous phenylephrine infusion at 50 mcg/min in preventing shivering after spinal anesthesia in cesarean section. This study was an open-label randomized clinical trial involving patients undergoing cesarean section under spinal anesthesia. Subjects were allocated into two groups: without phenylephrine and continuous phenylephrine infusion at 50 mcg/min. The primary outcome was the incidence of shivering during observation, assessed using the Crossley and Mahajan scale. Secondary outcomes included hypotension, ephedrine requirement, hemodynamic adverse events, and nausea vomiting.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

108

Conditions

Shivering Caused by Spinal Anesthesia

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Females aged 18-50 years. * Patients undergoing a Cesarean section procedure under spinal anesthesia. * Patients who are not in labor (non-labor). * Patients willing to participate in this study. Exclusion Criteria: * Patients with contraindications to phenylephrine. * Patients with allergies to the study medications. * Presence of fever (temperature \>37.5°C) or hypothermia (temperature \<35°C). * American Society of Anesthesiologists (ASA) score of III or higher. * Patients with a history of untreated thyroid disease. * Patients with a history of autonomic nervous system neuropathy. * Hypertension in pregnancy (or gestational hypertension). * Body Mass Index (BMI) greater than 35 kg/m².

Outcomes

Primary Outcomes

Shivering

incidence of shivering after spinal anestesia intraoperatively

Time frame: after the moment of spinal anesthesia until end of surgery

Secondary Outcomes

Hypotension

incidence of hypotension after spinal anesthesia, define as decreasing of more than 20% of blood pressure from baseline