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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07663149
Enrollment
108
Registered
2026-06-23
Start date
2026-04-07
Completion date
2026-06-07
Last updated
2026-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shivering Caused by Spinal Anesthesia

Keywords

spinal anesthesia, phenylephrine, cesarean section, hypotension, shivering

Brief summary

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.

Interventions

DRUGPhenylephrine

giving phenylephrine continous infusion at rate 50 mcg/minutes intravenously after insertion of spinal anesthesia

Sponsors

Indonesia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Shiveringafter the moment of spinal anesthesia until end of surgeryincidence of shivering after spinal anestesia intraoperatively

Secondary

MeasureTime frameDescription
Hypotensionafter the moment of spinal anesthesia until end of surgeryincidence of hypotension after spinal anesthesia, define as decreasing of more than 20% of blood pressure from baseline

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 24, 2026