Prophylactic Phenylephrine Co-administration During Caesarean Section

NCT04005664 | Completed

• 1 other identifier: BE616/17
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This single centre prospective alternating intervention study will aim to compare prophylactic phenylephrine given in the first litre of Ringers lactate as co-load in healthy patients having an elective caesarean section under spinal anaesthesia at Edendale Hospital to the existing national protocol guideline - for the treatment of obstetric spinal hypotension.

Conditions

Cesarean Section Complications; Anesthesia Complication

Outcome Measures

Primary Outcomes (1)

• Post spinal hypotension

  The incidence of post spinal hypotension (SBP \<90 mmHg)

  from insertion of spinal anaesthesia until the delivery of the baby

Secondary Outcomes (7)

• Maternal symptoms

  time of spinal insertion till delivery of the baby

• Maternal cardiac arrest

  time of spinal insertion till delivery of the baby

• Maternal bradycardia

  time of spinal insertion till delivery of the baby

• Requirement for vasopressor

  time of spinal insertion till delivery of the baby

• Highest blood pressure

  time of spinal insertion till delivery of the baby

Study Arms (2)

Bolus group

NO INTERVENTION

Hypotension occurring under spinal anaesthesia (SBP \< 90mmHg) requires pharmacological treatment. The pharmacological management of hypotension, once diagnosed, will be the same regardless of the protocol being used. If the heart rate is greater than 70 beats per minute, phenylephrine will be administered in a dose of 50-100 mcg as an intravenous bolus. If the heart rate is less than 70 beats per minute, ephedrine will be administered in a dose of 5-10 mg. The dose within this range will be decided by the attending anaesthetist. In both arms, Ringers Lactate fluid should run fast if hypotension occurs.

Phenylephrine coload group

ACTIVE COMPARATOR

Phenylephrine 500ug will be added to the first litre of ringer's lactate infused on initiation of spinal anaesthesia. If the phenylephrine infusion protocol is being used, and the mean arterial pressure (MAP) rises to greater than 20% of the initial MAP, and where this rise in MAP is not due to a recent bolus of either phenylephrine or ephedrine (within 2 minutes), the Ringers Lactate infusion will be switched off. The pharmacological management of hypotension, once diagnosed, will be the same regardless of the protocol being used. If the heart rate is greater than 70 beats per minute, phenylephrine will be administered in a dose of 50-100 mcg as an intravenous bolus. If the heart rate is less than 70 beats per minute, ephedrine will be administered in a dose of 5-10 mg. In both arms, Ringers Lactate fluid should run fast if hypotension occurs.

Drug: Phenylephrine

Interventions

Phenylephrine DRUG

Prophylactic phenylephrine infusion as part of fluid coload

Also known as: Phenylephrine coload

Phenylephrine coload group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All ASA 1-2 patients undergoing elective caesarean

You may not qualify if:

• ASA grade \>2 Hypertensive disease in pregnancy Dysrhythmia Failed spinal requiring conversion to a general anaesthetic

Sponsors & Collaborators

• University of KwaZulu: lead

Study Sites (1)

Edendale Hospital

Pietermaritzburg, KwaZulu-Natal, 3201, South Africa

Location

Related Publications (4)

• Kinsella SM, Carvalho B, Dyer RA, Fernando R, McDonnell N, Mercier FJ, Palanisamy A, Sia ATH, Van de Velde M, Vercueil A; Consensus Statement Collaborators. International consensus statement on the management of hypotension with vasopressors during caesarean section under spinal anaesthesia. Anaesthesia. 2018 Jan;73(1):71-92. doi: 10.1111/anae.14080. Epub 2017 Nov 1. No abstract available.

  PMID: 29090733 RESULT

• Bishop DG, Rodseth RN, Dyer RA. Recipes for obstetric spinal hypotension: The clinical context counts. S Afr Med J. 2016 Aug 1;106(9):861-4. doi: 10.7196/SAMJ.2016.v106i9.10877.

  PMID: 27601104 RESULT

• Bishop DG, Cairns C, Grobbelaar M, Rodseth RN. Prophylactic Phenylephrine Infusions to Reduce Severe Spinal Anesthesia Hypotension During Cesarean Delivery in a Resource-Constrained Environment. Anesth Analg. 2017 Sep;125(3):904-906. doi: 10.1213/ANE.0000000000001905.

  PMID: 28244952 RESULT

• Allen TK, George RB, White WD, Muir HA, Habib AS. A double-blind, placebo-controlled trial of four fixed rate infusion regimens of phenylephrine for hemodynamic support during spinal anesthesia for cesarean delivery. Anesth Analg. 2010 Nov;111(5):1221-9. doi: 10.1213/ANE.0b013e3181e1db21. Epub 2010 May 21.

  PMID: 20495139 RESULT

MeSH Terms

Interventions

Phenylephrine

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Officials

• David G Bishop, PhD

  University of KwaZulu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single centre prospective alternating intervention study

Study Record Dates

• First Submitted: June 19, 2019
• First Posted: July 2, 2019
• Study Start: May 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: July 2, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)