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Completed

NCT Number: NCT04133961

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

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

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Key information

Conditions

Postoperative Shivering

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Pusat Perubatan Universiti Kebangsaan Malaysia

Kuala Lumpur, 56000, Malaysia

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Phenylephrine

Drug

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

normal saline

Drug

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

Primary outcomes

  1. Presence and intensity of shivering

    Time frame: 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 outcomes

  1. Change in patient's core and skin temperature

    Time frame: 2 hours

    Patient's core (tympanic membrane) and skin (forehead) temperature is measured using an infrared thermometer.

Sponsors and collaborators

Lead sponsor

Universiti Kebangsaan Malaysia Medical Centre

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Oct 21, 2019
Registry last updated
Jul 8, 2020

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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