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Completed

NCT Number: NCT03302039

Three Protocols for Phenylephrine Administration in Cesarean Delivery

The investigators will compare variable infusion of phenylephrine (at a starting rate of 0.75 mcg/Kg/min) with fixed rate (0.75 mcg/Kg/min which will stop of reactive hypertension occurred) and single shot (1.5 mcg/Kg) phenylephrine.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Cairo University

Cairo, Egypt

About this study

Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Phenylephrine (PE) is the most popular vasopressor for prevention of post-spinal hypotension (PSH) during CD; however, the most appropriate protocol for PE administration is still unknown. The most common PE protocols used for prophylaxis against PSH are: single shot, fixed infusion, and variable infusion. A recent study reported that a dose of 1.5 mcg/Kg is the most suitable single-shot dose for prophylaxis. Another randomized controlled trial compared four doses of PE infusion and reported that 25 mcg/Kg/min and 50 mcg/Kg/min doses were the best doses for fixed infusion with accepted incidence of both PSH as well as reactive hypertension. Using variable infusion rate of PE had been recently introduced in another study with a starting dose of 0.75 mcg/Kg/min. The variable rate infusion showed very good results regarding PSH. In this study, the investigators will compare variable infusion of PE (at a starting rate of 0.75 mcg/Kg/min) with fixed rate (0.75 mcg/Kg/min which will stop if reactive hypertension occurred) and single shot protocol (1.5 mcg/Kg).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Full term
  • Pregnant women
  • Scheduled for cesarean delivery

Exclusion criteria

  • Pre-eclampsia
  • Eclampsia
  • Hemorrhage
  • Cardiac dysfunction
  • Baseline low heart rate (below 60 bpm)

Treatment and study plan

Single shot phenylephrine

Drug

A single shot of phenylephrine (1.5 mcg/Kg) will be administrated intravenously.

Other names: Phenylephrine

Fixed infusion phenylephrine.

Drug

Fixed infusion of phenylephrine will be administrated at a rate of 0.75 mcg/Kg/min

Other names: Phenylephrine

Variable infusion phenylephrine.

Drug

Variable infusion of phenylephrine will be administrated at a starting rate of 0.75 mcg/Kg/min.

Other names: Phenylephrine

Bupivacaine

Drug

Bupivacaine will be administrated in the subarachnoid space for spinal anesthesia.

Other names: Marcaine

Primary outcomes

  1. Incidence of Post-spinal anesthesia hypotension

    Time frame: 30 minutes after spinal anesthesia

    Defined as percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading during the period from intrathecal injection to delivery of the fetus

Secondary outcomes

  1. Incidence of severe Post-spinal anesthesia hypotension

    Time frame: 30 minutes after spinal anesthesia

    Defined as percentage of patients with decreased systolic blood pressure less than 60% of the baseline reading during the period from intrathecal injection to delivery of the fetus.

  2. Incidence of reactive hypertension

    Time frame: 2 hours after spinal anesthesia

    Defined as percentage of patients with increased systolic blood pressure more than 80% of the baseline reading during the period from intrathecal injection to delivery of the fetus.

  3. Systolic blood pressure

    Time frame: 2 hours after spinal anesthesia

    Systolic blood pressure measured in mmHg

  4. Diastolic blood pressure

    Time frame: 2 hours after spinal anesthesia

    Diastolic blood pressure measured in mmHg

  5. Heart rate

    Time frame: 2 hours after spinal anesthesia

    number of heart beats per minute

  6. APGAR score

    Time frame: 10 minutes after delivery

    APGAR score of the fetus

  7. umbilical arterial PH

    Time frame: 10 minutes after delivery

    the PH in umbilical arterial blood

  8. umbilical arterial Pco2

    Time frame: 10 minutes after delivery

    umbilical arterial Pco2 measured in mmHg

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Three Protocols for Phenylephrine Administration for Prophylaxis Against Post-spinal Hypotension During Cesarean Delivery

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 4, 2017
Registry last updated
Dec 17, 2018

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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