Vasopressor Infusion in Cesarean Delivery

Comparison of Two Vasopressor Infusion for Prevention of Post-spinal Hypotension During Cesarean Delivery: A Randomized Controlled Trial

Comparison will be conducted between continuous variable infusions of both drugs (Phenylephrine and Norepinephrine) with starting doses of 0.75 mcg/Kg/min and 0.1 mcg/Kg/min respectively for prophylaxis against Post-spinal hypotension during cesarean delivery.

Study Overview

• Status: Recruiting
• Conditions: Cesarean Section Complications; Spinal Anesthesia
• Intervention / Treatment: Drug: Phenylephrine; Drug: Bupivacaine; Drug: Norepinephrine

Detailed Description

Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Many vasopressors have been used for prevention of post-spinal hypotension (PSH) during CD; however, the optimum protocol for prophylaxis is not established yet. Phenylephrine (PE) is a popular vasopressor used in obstetric anesthesia; however, its use is limited by its marked cardiac depressant nature. Norepinephrine (NE) is a potent vasopressor characterized by both α adrenergic agonistic activity in addition to a weak β adrenergic agonistic activity; thus, NE is considered a vasopressor with minimal cardiac depressant effect; these pharmacological properties would make NE an attractive alternative to PE. In this study, we will compare continuous variable infusion of both drugs (PE and NE) with doses of 0.75 mcg/Kg/min and 0.1 mcg/Kg/min respectively for prophylaxis against PSH during CD.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• 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
    • Contact: ahmed Shash, Professor; Phone Number: +201001033999

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 section

Exclusion Criteria:

• pre-ecpamsia
• eclampsia
• bleeding
• cardiac dysfuction

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Phenylephrine; Will receive spinal anesthesia using Bupivacaine. Then, phenylephrine infusion by a starting rate of 0.75 mcg/Kg/min. The rate will be then adjusted according to the patient blood pressure	Drug: Phenylephrine; Phenylephrine variable infusion with a starting rate of 0.75 mcg/Kg/min.; Drug: Bupivacaine; Bupivacaine will be injected in the subarachnoid space with a dose of 10 mg; Other Names: Marcaine
Experimental: Norepinephrine; Will receive spinal anesthesia using Bupivacaine. Then, norepinephrine infusion by a starting rate of 0.1 mcg/Kg/min. The rate will be then adjusted according to the patient blood pressure	Drug: Bupivacaine; Bupivacaine will be injected in the subarachnoid space with a dose of 10 mg; Other Names: Marcaine; Drug: Norepinephrine; Norepinephrine variable infusion with a starting rate of 0.1 mcg/Kg/min.; Other Names: noradrenaline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of post-spinal anesthesia hypotension	Defined as the percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading	30 minutes after spinal anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
APGAR score	APGAR score of the fetus	10 minutes after delivery
incidence of severe post-spinal anesthesia hypotension	Defined as the percentage of patients with decreased systolic blood pressure less than 60% of the baseline reading	30 minutes after spinal anesthesia
incidence of severe delivery hypotension	Defined as the percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading	10 minutes after delivery
systolic blood pressure	systolic blood pressure measured in mmHg	2 hours after subarachnoid block
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
incidence of reactive hypertension	Defined as the percentage of patients with increased systolic blood pressure more than 80% of the baseline reading	2 hours after spinal anesthesia

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2017
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): March 10, 2022

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): September 27, 2021
• Last Update Submitted That Met QC Criteria: September 22, 2021
• Last Verified: September 1, 2021

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; Norepinephrine; Phenylephrine; Oxymetazoline
• Other Study ID Numbers: N-86-2017

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