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NCT Number: NCT07663149

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

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.

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Key information

Conditions

Shivering Caused by Spinal Anesthesia Cardiovascular Diseases Hypotension Vascular Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

RSUP dr. Cipto Mangunkusumo

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Phenylephrine

Drug

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

Primary outcomes

  1. Shivering

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

    incidence of shivering after spinal anestesia intraoperatively

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 23, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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