Phenylephrine Infusion in Cesarean Delivery

Comparison of Different Protocols of Phenylephrine Infusion for Prophylaxis Against Post-spinal Hypotension During 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

Study Overview

• Status: Unknown
• Conditions: Cesarean Section Complications; Spinal Anesthesia
• Intervention / Treatment: Drug: single shot phenylephrine; Drug: Bupivacaine; Drug: fixed infusion phenylephrine; Drug: variable infusion phenylephrine

Detailed Description

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)

• Study Type: Interventional
• Enrollment (Anticipated): 255
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: ahmed hasanin, Professor; Phone Number: +201095076954; Email: ahmedmohamedhasanin@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: single shot; spinal anesthesia will be performed using intrathecal bupivacaine. Then, a single shot phenylephrine (1.5 ug/Kg) will be administered	Drug: single shot phenylephrine; a single shot of phenylephrine (1.5 mcg/Kg) will be administrated intravenously; Other Names: phenylephrine; Drug: Bupivacaine; Bupivacaine will be administrated in the subarachnoid space for spinal anesthesia; Other Names: marcaine
Active Comparator: fixed infusion; spinal anesthesia will be performed using intrathecal bupivacaine. Then, fixed infusion phenylephrine will be administered at a dose of (0.75 mcg/Kg/min). the infusion will stop if reactive hypertension occurred	Drug: Bupivacaine; Bupivacaine will be administrated in the subarachnoid space for spinal anesthesia; Other Names: marcaine; Drug: fixed infusion phenylephrine; fixed infusion of phenylephrine will be administrated at a rate of 0.75 mcg/Kg/min.; Other Names: phenylephrine
Active Comparator: variable infusion; spinal anesthesia will be performed using intrathecal bupivacaine. Then, variable infusion phenylephrine will be administered at a starting dose of (0.75 mcg/Kg/min). the infusion will be titrated according to blood pressure	Drug: Bupivacaine; Bupivacaine will be administrated in the subarachnoid space for spinal anesthesia; Other Names: marcaine; Drug: variable infusion phenylephrine; Variable infusion of phenylephrine will be administrated at a starting rate of 0.75 mcg/Kg/min.; Other Names: phenylephrine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Post-spinal anesthesia hypotension	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.	30 minutes after spinal anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of severe Post-spinal anesthesia hypotension	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.	30 minutes after spinal anesthesia
Incidence of reactive hypertension	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.	2 hours after spinal anesthesia
APGAR score	APGAR score of the fetus	10 minutes after delivery
diastolic blood pressure	diastolic blood pressure measured in mmHg	2 hours after subarachnoid block
heart rate	number of heart beats per minute	2 hours after subarachnoid block
systolic blood pressure	systolic blood pressure measured in mmHg	2 hours after spinal anesthesia

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2017
• Primary Completion (Anticipated): May 15, 2020
• Study Completion (Anticipated): May 25, 2020

Study Registration Dates

• First Submitted: August 10, 2017
• First Submitted That Met QC Criteria: August 11, 2017
• First Posted (Actual): August 14, 2017

Study Record Updates

• Last Update Posted (Actual): November 25, 2019
• Last Update Submitted That Met QC Criteria: November 22, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Protective Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Cardiotonic Agents; Anesthetics, Local; Respiratory System Agents; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Nasal Decongestants; Adrenergic alpha-1 Receptor Agonists; Bupivacaine; Phenylephrine; Oxymetazoline
• Other Study ID Numbers: N-87-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No