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

Postoperative Shivering Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04133961
• Other study ID #: FF-2019-273
• Status: Completed
• Phase: N/A
• Start date: June 12, 2019
• Est. completion date: January 1, 2020

Study information

• Verified date: October 2019
• Source: Universiti Kebangsaan Malaysia Medical Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: January 1, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Shivering

Intervention

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

Locations

Country	Name	City	State
Malaysia	Pusat Perubatan Universiti Kebangsaan Malaysia	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Kebangsaan Malaysia Medical Centre

Country where clinical trial is conducted

Malaysia, 

References & Publications (4)

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. — View Citation

Hilton, E.J., Wilson, S.H., Wolf, B.J., Hand, W., Roberts, L. & Hebbar, L. 2015. Effect of intraoperative phenylephrine infusion on redistribution hypothermia during caesarean delivery under spinal anesthesia. Journal of Clinical Anesthesia and Management 1(1): 1-4.

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence and intensity of shivering	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).	2 hours
Secondary	Change in patient's core and skin temperature	Patient's core (tympanic membrane) and skin (forehead) temperature is measured using an infrared thermometer.	2 hours