Vasopressor Prophylaxis After Spinal Anesthesia

Vasopressor Prophylaxis After Spinal Anesthesia: A Dose Finding Study

Norepinephrine has been recently introduced as a prophylactic vasopressor during Cesarean delivery with promising results ; However, the optimum dose for efficient prophylaxis with the least side effects is not known. In this study, we will compare three doses (0.05, 0.1, 0.15 mcg/Kg/min) of norepinephrine for prophylaxis against Post-Spinal hypotension during cesarean delivery.

Study Overview

• Status: Completed
• Conditions: Cesarean Section Complications
• Intervention / Treatment: Drug: Norepinephrine 0.05 mcg /Kg/min; Drug: Bupivacaine; Drug: Norepinephrine 0.1 mcg /Kg/min; Drug: Norepinephrine 0.15 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 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 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, we will compare three doses (0.05, 0.1, 0.15 mcg/Kg/min) of norepinephrine for prophylaxis against PSH during CD.

• Study Type: Interventional
• Enrollment (Actual): 270
• 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
• Aged between 18 and 40 years

Exclusion Criteria:

• Cardiac morbidities
• Hypertensive disorders of pregnancy,
• Peripartum bleeding
• Baseline systolic blood pressure (SBP) < 100 mmHg
• Body mass index > 35

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: - 0.05 mcg /Kg/min group; will receive norepinephrine 0.05 mcg /Kg/min after spinal anesthesia by bupivacaine till five-minutes after delivery of the fetus	Drug: Norepinephrine 0.05 mcg /Kg/min; Norepinephrine infusion by rate of 0.05 mcg /Kg/min after spinal anesthesia; Other Names: noradrenaline infusion; Drug: Bupivacaine; 10 mg Bupivacaine intra-thecal for spinal anesthesia; Other Names: marcaine
EXPERIMENTAL: - 0.1 mcg /Kg/min group; will receive norepinephrine 0.1 mcg /Kg/min after spinal anesthesia by bupivacaine till five-minutes after delivery of the fetus	Drug: Bupivacaine; 10 mg Bupivacaine intra-thecal for spinal anesthesia; Other Names: marcaine; Drug: Norepinephrine 0.1 mcg /Kg/min; Norepinephrine infusion by rate of 0.05 mcg /Kg/min after spinal anesthesia; Other Names: noradrenaline infusion
EXPERIMENTAL: - 0.15 mcg /Kg/min group; will receive norepinephrine 0.15 mcg /Kg/min after spinal anesthesia by bupivacaine till five-minutes after delivery of the fetus	Drug: Bupivacaine; 10 mg Bupivacaine intra-thecal for spinal anesthesia; Other Names: marcaine; Drug: Norepinephrine 0.15 mcg /Kg/min; Norepinephrine infusion by rate of 0.05 mcg /Kg/min after spinal anesthesia; Other Names: noradrenaline infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of 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
heart rate	heart rate after spinal anesthesia measured in beat per minute	90 minutes after spinal anesthesia
vomiting	incidence of vomiting after spinal anesthesia	120 minutes after spinal anesthesia
nausea	incidence of nausea after spinal anesthesia	120 minutes after spinal anesthesia
ephedrine consumption	total amount of ephedrine consumed after spinal anesthesia	60 minutes after spinal anesthesia
Atropine consumption	total amount of atropine consumed after spinal anesthesia	60 minutes after spinal anesthesia
APGAR score	APGAR score of the delivered fetus	10 minutes after delivery
incidence of 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
arterial blood pressure	arterial blood pressure after spinal anesthesia measured in mmHg	90 minutes after spinal anesthesia

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 2, 2017
• Primary Completion (ACTUAL): November 2, 2018
• Study Completion (ACTUAL): December 10, 2018

Study Registration Dates

• First Submitted: July 27, 2017
• First Submitted That Met QC Criteria: July 27, 2017
• First Posted (ACTUAL): July 31, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 15, 2019
• Last Update Submitted That Met QC Criteria: January 13, 2019
• Last Verified: January 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; Adrenergic alpha-Agonists; Adrenergic Agonists; Anesthetics, Local; Sympathomimetics; Vasoconstrictor Agents; Bupivacaine; Norepinephrine
• Other Study ID Numbers: N_66_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