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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: December 1, 2019

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

  • Drug: Phenylephrine
    • Phenylephrine infusion 0.3ml/kg/hour (equivalent to 0.5mcg/kg/min, phenylephrine dilution is 100mcg/ml in 20ml syringe)
  • Drug: Normal saline
    • Normal saline infusion 0.3ml/kg/hour (normal saline in 20ml syringe)

Arms, Groups and Cohorts

  • Experimental: Group A (Phenylephrine)
    • Phenylephrine infusion started immediately after administration of spinal block
  • Placebo Comparator: Group B (Saline)
    • Normal saline infusion started immediately after administration of spinal block

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: Female

Patients who are planned for elective lower segment caesarean section

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Universiti Kebangsaan Malaysia Medical Centre
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Syarifah Noor Nazihah Sayed Masri, MD, Principal Investigator, Anaesthesiologist

References

Ikeda T, Ozaki M, Sessler DI, Kazama T, Ikeda K, Sato S. Intraoperative phenylephrine infusion decreases the magnitude of redistribution hypothermia. Anesth Analg. 1999 Aug;89(2):462-5.

Ro Y, Huh J, Min S, Han S, Hwang J, Yang S, Kim DK, Kim C. Phenylephrine attenuates intra-operative hypothermia during spinal anaesthesia. J Int Med Res. 2009 Nov-Dec;37(6):1701-8.

Hilton EJ, Wilson SH, Wolf BJ, Hand W, Roberts L, Hebbar L. Effect of Intraoperative Phenylephrine Infusion on Redistribution Hypothermia During Cesarean Delivery Under Spinal Anesthesia. J Clin Anesth Manag. 2016 Jan;1(1). doi: 10.16966/2470-9956.103. Epub 2015 Dec 19.

Badjatia N, Strongilis E, Gordon E, Prescutti M, Fernandez L, Fernandez A, Buitrago M, Schmidt JM, Ostapkovich ND, Mayer SA. Metabolic impact of shivering during therapeutic temperature modulation: the Bedside Shivering Assessment Scale. Stroke. 2008 Dec;39(12):3242-7. doi: 10.1161/STROKEAHA.108.523654. Epub 2008 Oct 16.

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