Intraoperative Phenylephrine Infusion to Reduce Postoperative Shivering in Lower Segment Caesarean Section

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04133961

Enrollment

118

Registered

2019-10-21

Start date

2019-06-12

Completion date

2020-01-01

Last updated

2020-07-08

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

Conditions

Postoperative Shivering

Keywords

Phenylephrine, Spinal anaesthesia

Brief summary

Assessment of whether and how phenylephrine infusion reduces postoperative shivering in spinal anaesthesia.

Detailed description

This study aims to evaluate whether phenylephrine infusion can reduce postoperative shivering among patients scheduled for elective lower segment caesarean section under spinal anaesthesia.

Interventions

DRUGPhenylephrine

Phenylephrine infusion 0.3ml/kg/hour (equivalent to 0.5mcg/kg/min, phenylephrine dilution is 100mcg/ml in 20ml syringe)

DRUGNormal saline

Normal saline infusion 0.3ml/kg/hour (normal saline in 20ml syringe)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* More than 18 years of age * American Society of Anesthesiologists (ASA) II patients * Patients with singleton pregnancy who are scheduled to undergo elective lower segment caesarean section under spinal anaesthesia

Exclusion criteria

* Patients with contraindication to phenylephrine * Patients with evidence of fever or infection, or hypothermia preoperatively * BMI ≥ 40 * Height \<150cm

Design outcomes

Primary

Measure	Time frame	Description
Presence and intensity of shivering	2 hours	Any presence of shivering intraoperatively is recorded. The intensity of shivering is recorded based on the Bedside Shivering Assessment Scale (BSAS) with a scoring of 0-3 (0 = no shivering, 1 = shivering localised to neck and/or thorax, 2 = shivering involves gross movement of upper extremities, 3 = shivering involves gross movements of the trunk, upper and lower extremities).

Secondary

Measure	Time frame	Description
Change in patient's core and skin temperature	2 hours	Patient's core (tympanic membrane) and skin (forehead) temperature is measured using an infrared thermometer.

Countries

Malaysia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026