Norepinephrine Infusion Different Doses in Cesarean Delivery

Norepinephrine Infusion for Prevention of Post-spinal Hypotension During Cesarean Delivery: A Randomized Controlled Dose Finding Trial.

three doses (0.025 mcg/Kg/min, 0.050 mcg/Kg/min, and 0.075 mcg/Kg/min) of norepinephrine will be compared for prophylaxis against Post-spinal anesthesia hypotension during Cesarean delivery.

Study Overview

• Status: Completed
• Conditions: Cesarean Section Complications
• Intervention / Treatment: Drug: norepinephrine infusion (0.025 mcg/Kg/min); Drug: Bupivacaine; Drug: norepinephrine infusion (0.050 mcg/Kg/min); Drug: norepinephrine infusion (0.075 mcg/Kg/min)

Detailed Description

Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Using vasopressors have been considered a gold standard for prevention of post-spinal hypotension (PSH) during CD.

Norepinephrine (NE) is a potent vasopressor characterized by both α adrenergic agonist activity in addition to a weak β adrenergic agonist activity; thus, NE is considered a vasopressor with minimal cardiac depressant effect; these pharmacological properties would make NE an attractive alternative to phenylephrine and ephedrine (the most commonly used vasopressors in obstetric anesthesia).

Norepinephrine has been recently introduced as a prophylactic vasopressor during CD with promising results; However, the optimum dose for efficient prophylaxis with the least side effects is not known.

In this study, three doses (0.025, 0.050, 0.075 mcg/Kg/min) of norepinephrine will be compared for prophylaxis against PSH during CD.

• Study Type: Interventional
• Enrollment (Actual): 284
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • 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
• singleton
• pregnant women
• scheduled for elective cesarean delivery

Exclusion Criteria:

• cardiac morbidities
• hypertensive disorders of pregnancy
• peripartum bleeding
• baseline systolic blood pressure (SBP) < 100 mmHg
• body mass index > 35 will be excluded from the study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 0.025 mcg /Kg/min group; The patients will receive spinal anesthesia through 10 mg Bupivacaine, then start norepinephrine bitartrate infusion (0.05 mcg/Kg/min) equivalent to norepinephrine infusion (0.025 mcg/Kg/min).	Drug: norepinephrine infusion (0.025 mcg/Kg/min); The patients will receive a bolus of 5 mcg norepinephrine followed by norepinephrine bitartrate infusion of (0.05 mcg/Kg/min) equivalent to norepinephrine base of (0.025 mcg/Kg/min); Other Names: noradrenaline infusion; Drug: Bupivacaine; The patient will receive spinal anesthesia using Bupivacaine (10 mg).; Other Names: spinal anesthesia; Heavy marcaine
Experimental: 0.050 mcg/Kg/min group; The patients will receive spinal anesthesia through 10 mg Bupivacaine, then start norepinephrine bitartrate infusion (0.1 mcg/Kg/min) equivalent to norepinephrine infusion (0.050 mcg/Kg/min).	Drug: Bupivacaine; The patient will receive spinal anesthesia using Bupivacaine (10 mg).; Other Names: spinal anesthesia; Heavy marcaine; Drug: norepinephrine infusion (0.050 mcg/Kg/min); The patients will receive a bolus of 5 mcg norepinephrine followed by norepinephrine infusion of (0.1 mcg/Kg/min) equivalent to norepinephrine base of (0.050 mcg/Kg/min); Other Names: noradrenaline infusion
Experimental: 0.075 mcg/Kg/min group; The patients will receive spinal anesthesia through 10 mg Bupivacaine, then start norepinephrine bitartrate infusion (0.15 mcg/Kg/min) equivalent to norepinephrine infusion (0.075 mcg/Kg/min)	Drug: Bupivacaine; The patient will receive spinal anesthesia using Bupivacaine (10 mg).; Other Names: spinal anesthesia; Heavy marcaine; Drug: norepinephrine infusion (0.075 mcg/Kg/min); The patients will receive a bolus of 5 mcg norepinephrine followed by norepinephrine infusion of (0.15 mcg/Kg/min) equivalent to norepinephrine base of (0.075 mcg/Kg/min).; Other Names: noradrenaline infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postspinal hypotension	The number of patients who develop hypotension (defined as decreased SBP less than 80% of the baseline reading during the period from intrathecal injection till delivery of the fetus) after spinal block divided by the total number in the group	30 minutes after spinal anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
severe postspinal hypotension	The number of patients who develop hypotension (defined as decreased SBP less than 60% of the baseline reading during the period from intrathecal injection till delivery of the fetus) after spinal block divided by the total number in the group	30 minutes after spinal anesthesia
Post-delivery hypotension	number of patients who develop hypotension (defined as decreased SBP less than 80% of the baseline reading after delivery of the fetus and starting oxytocin infusion)	10 minutes after delivery
systolic blood pressure	systolic blood pressure measured in mmHg	60 minutes after spinal block
diastolic blood pressure	diastolic blood pressure measured in mmHg	60 minutes after spinal block
heart rate	heart rate measured in beats per minute	60 minutes after spinal block
intraoperative hypertension	number of patients who develop intraoperive hypertension (defined as increased systolic blood pressure by more than 20% of the baseline reading) divided by the total number of patients in the group	60 minutes after spinal block
incidence of nausea and vomiting	number of patients who develop nausea and vomiting divided by the total number of patients in the group	60 minutes after spinal block
ephedrine consumption	total amount of ephedrine consumed during the operation (measured in milligrams)	60 minutes after spinal block
Atropine consumption	total amount of atropine consumed during the operation (measured in milligrams)	60 minutes after spinal block
APGAR score	APGAR score for detection of the well being of the fetus	1 minute after delivery
APGAR score	APGAR score for detection of the well being of the fetus	10 minutes after delivery

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2017
• Primary Completion (Actual): December 25, 2017
• Study Completion (Actual): December 30, 2017

Study Registration Dates

• First Submitted: June 7, 2017
• First Submitted That Met QC Criteria: June 8, 2017
• First Posted (Actual): June 9, 2017

Study Record Updates

• Last Update Posted (Actual): August 24, 2018
• Last Update Submitted That Met QC Criteria: August 23, 2018
• Last Verified: August 1, 2018

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; Adrenergic alpha-Agonists; Adrenergic Agonists; Anesthetics, Local; Sympathomimetics; Vasoconstrictor Agents; Bupivacaine; Norepinephrine
• Other Study ID Numbers: N-49-2017

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
• product manufactured in and exported from the U.S.: No