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Completed

NCT Number: NCT04005664

Prophylactic Phenylephrine Co-administration During Caesarean Section

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.

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Key information

Conditions

Cesarean Section Complications Anesthesia Complication

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Edendale Hospital

Pietermaritzburg, KwaZulu-Natal, 3201, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phenylephrine

Drug

Prophylactic phenylephrine infusion as part of fluid coload

Other names: Phenylephrine coload

Primary outcomes

  1. Post spinal hypotension

    Time frame: from insertion of spinal anaesthesia until the delivery of the baby

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

Secondary outcomes

  1. Maternal symptoms

    Time frame: time of spinal insertion till delivery of the baby

    nausea, vomiting, headache and dizziness.

  2. Maternal cardiac arrest

    Time frame: time of spinal insertion till delivery of the baby

    Requirement for cardiopulmonary resuscitation

  3. Maternal bradycardia

    Time frame: time of spinal insertion till delivery of the baby

    maternal bradycardia requiring atropine administration

  4. Requirement for vasopressor

    Time frame: time of spinal insertion till delivery of the baby

    Number of vasopressor boluses

  5. Highest blood pressure

    Time frame: time of spinal insertion till delivery of the baby

    Highest systolic blood pressure (mmHg)

  6. Lowest blood pressure

    Time frame: time of spinal insertion till delivery of the baby

    Lowest systolic blood pressure (mmHg)

  7. Lowest maternal heart rate

    Time frame: time of spinal insertion till delivery of the baby

    Lowest heart rate (beats per minute)

Sponsors and collaborators

Lead sponsor

University of KwaZulu

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 2, 2019
Registry last updated
Jul 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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