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

Not Applicable

Completed

• Conditions: Postoperative Shivering
• Interventions: Drug: Normal saline; Drug: Phenylephrine

• Registration Number: NCT04133961
• Lead Sponsor: Universiti Kebangsaan Malaysia Medical Centre

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.

Study Timeline

• Study Start: 2019-06-12
• Status Verified: 2019-10
• Study First Submitted: 2019-10-11
• Study First Submitted QC: 2019-10-17
• Study First Posted: 2019-10-21
• Primary Completion: 2019-12-01
• Study Completion: 2020-01-01
• Last Update Submitted: 2020-07-05
• Last Update Posted: 2020-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 118

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B (Saline)	Normal saline	Normal saline infusion started immediately after administration of spinal block
Group A (Phenylephrine)	Phenylephrine	Phenylephrine infusion started immediately after administration of spinal block

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Pusat Perubatan Universiti Kebangsaan Malaysia; 🇲🇾 Kuala Lumpur, Malaysia