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

June 17, 2026 updated by: Alfan Mahdi Nugroho, Indonesia University

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Jakarta Special Capital Region
      • Jakarta Pusat, Jakarta Special Capital Region, Indonesia, 10430
        • RSUP dr. Cipto Mangunkusumo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phenylephrine group
This group will be given an intervention of phenylephrine continous infusion at rate 50 mcg/min
Drug: Phenylephrine
giving phenylephrine continous infusion at rate 50 mcg/minutes intravenously after insertion of spinal anesthesia
No Intervention: Without Phenylephrine group
this group doesnt receive any intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shivering
Time Frame: after the moment of spinal anesthesia until end of surgery
incidence of shivering after spinal anestesia intraoperatively
after the moment of spinal anesthesia until end of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypotension
Time Frame: after the moment of spinal anesthesia until end of surgery
incidence of hypotension after spinal anesthesia, define as decreasing of more than 20% of blood pressure from baseline
after the moment of spinal anesthesia until end of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2026

Primary Completion (Actual)

June 7, 2026

Study Completion (Actual)

June 7, 2026

Study Registration Dates

First Submitted

June 17, 2026

First Submitted That Met QC Criteria

June 17, 2026

First Posted (Actual)

June 23, 2026

Study Record Updates

Last Update Posted (Actual)

June 23, 2026

Last Update Submitted That Met QC Criteria

June 17, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26-01-0013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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