Prophylactic Phenylephrine Co-administration During Caesarean Section

Cesarean Section Complications Clinical Trial

Official title:

Prophylactic Phenylephrine and Fluid Co-administration to Reduce Spinal Hypotension During Elective Caesarean Section in a Resource-limited Setting: a Prospective Alternating Intervention Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04005664
• Other study ID #: BE616/17
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: July 2019
• Source: University of KwaZulu
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Spinal anaesthesia is currently standard of care for patients undergoing caesarean section. Obstetric spinal hypotension is a common and important problem, related to important maternal and foetal outcomes. The prevention and treatment of spinal hypotension has been well researched in resource-rich settings, a context different from that encountered in the South African setting. It has been previously shown that a prophylactic phenylephrine infusion is effective in resource-limited settings, but this method is still dependent on the availability of an infusion pump.The ideal dose offering the best risk to benefit profile is 25 to 50 mcg/min. It has recently been shown that a prophylactic phenylephrine infusion, administered by an infusion pump, appears safe and effective in resource-constrained environments. However, some institutions in South Africa are limited by a lack of available infusion pumps. There is an urgent need to translate these research findings into a pragmatic management strategy that is safe and effective where this equipment is lacking. A 18g Jelco allows flow of approximately 100 ml/min in the absence of a pressure bag: therefore with 500 mcg in 1000 ml of ringers lactate and a fully opened line, a maximum dose of 50 mcg.min-1 will be achieved. If the rate is 50 ml/min (20 minutes for the first litre) the dose will be 25 mcg.min-1. This dose range will offer maximum benefit with low risk of side effects.

This exploratory study will establish if a phenylephrine (500 mcg) bolus, added to the first litre of Ringers lactate given as a co-load, is an effective and safe means to prevent post obstetric spinal hypotension. This regime will be compared to the existing South African national protocol of the management of obstetric spinal hypotension. The findings of this study will provide valuable information regarding a safe and potentially effective means to prevent obstetric spinal hypotension.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All ASA 1-2 patients undergoing elective caesarean

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Anesthesia Complication
• Cesarean Section Complications

Intervention

Drug:
• Phenylephrine
Prophylactic phenylephrine infusion as part of fluid coload

Locations

Country	Name	City	State
South Africa	Edendale Hospital	Pietermaritzburg	KwaZulu-Natal

Sponsors (1)

Lead Sponsor	Collaborator
University of KwaZulu

Country where clinical trial is conducted

South Africa, 

References & Publications (4)

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. — View Citation

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.0000 — View Citation

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. Review. — View Citation

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 caesar — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post spinal hypotension	The incidence of post spinal hypotension (SBP <90 mmHg)	from insertion of spinal anaesthesia until the delivery of the baby
Secondary	Maternal symptoms	nausea, vomiting, headache and dizziness.	time of spinal insertion till delivery of the baby
Secondary	Maternal cardiac arrest	Requirement for cardiopulmonary resuscitation	time of spinal insertion till delivery of the baby
Secondary	Maternal bradycardia	maternal bradycardia requiring atropine administration	time of spinal insertion till delivery of the baby
Secondary	Requirement for vasopressor	Number of vasopressor boluses	time of spinal insertion till delivery of the baby
Secondary	Highest blood pressure	Highest systolic blood pressure (mmHg)	time of spinal insertion till delivery of the baby
Secondary	Lowest blood pressure	Lowest systolic blood pressure (mmHg)	time of spinal insertion till delivery of the baby
Secondary	Lowest maternal heart rate	Lowest heart rate (beats per minute)	time of spinal insertion till delivery of the baby