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

NCT07663149 | Completed

• 1 other identifier: 26-01-0013
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Shivering Caused by Spinal Anesthesia

Keywords

spinal anesthesia; phenylephrine; cesarean section; hypotension; shivering

Outcome Measures

Primary Outcomes (1)

• Shivering

  incidence of shivering after spinal anestesia intraoperatively

  after the moment of spinal anesthesia until end of surgery

Secondary Outcomes (1)

• Hypotension

  after the moment of spinal anesthesia until end of surgery

Study Arms (2)

Phenylephrine group

EXPERIMENTAL

This group will be given an intervention of phenylephrine continous infusion at rate 50 mcg/min

Drug: Phenylephrine

Without Phenylephrine group

NO INTERVENTION

this group doesnt receive any intervention

Interventions

Phenylephrine DRUG

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

Phenylephrine group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: because the partipant was pregnant woman
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

RSUP dr. Cipto Mangunkusumo

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Location

MeSH Terms

Conditions

Hypotension

Interventions

Phenylephrine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr. Alfan Mahdi Nugroho Sp.An-TI, Subsp.AO(K), Subsp.AR(K)

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 23, 2026
• Study Start: April 7, 2026
• Primary Completion: June 7, 2026
• Study Completion: June 7, 2026
• Last Updated: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)