Comparison of Vasopressor Boluses for Management of Hypotension After Spinal Anesthesia

In this study the investigators will compare the efficacy and side effects of two doses of norepinephrine bolus (6 mcg and 10 mcg) in management of maternal hypotensive episode after subarachnoid block during Cesarean delivery.

Study Overview

• Status: Recruiting
• Conditions: Cesarean Section Complications; Spinal Anesthetic Toxicity
• Intervention / Treatment: Drug: Norepinephrine 6 mcg; Drug: Norepinephrine 10 mcg; Drug: Bupivacaine Hydrochloride; Drug: Norepinephrine infusion

Detailed Description

Maternal hypotension after subarachnoid block is a frequent and deleterious complication during cesarean delivery. Although prophylaxis against hypotension using vasopressors had become a standard recommendation; the incidence of hypotension is still ∼ 20% . Thus; management of maternal hypotension using vasopressor boluses is usually needed .

The commonly used vasopressors during cesarean delivery are ephedrine, phenylephrine, and recently norepinephrine. The use of ephedrine is usually accompanied with maternal tachycardia and fetal acidosis. Phenylephrine had been the first line for prevention and management of maternal hypotension; however, its use might result in bradycardia and decreased maternal cardiac output .

Norepinephrine is an alpha adrenergic agonist with weak beta adrenergic agonistic activity; thus, it does not cause significant cardiac depression as phenylephrine does. Norepinephrine was introduced for use during cesarean delivery with promising results . Few previous studies investigated the efficacy of Norepinephrine infusion for prevention of maternal hypotension. A dose-response study had investigated the best dose of Norepinephrine for prevention of maternal hypotension. In the aforementioned dose-response study, a dose of 6 mcg was reported as the best dose for prophylaxis against maternal hypotension.

No studies had investigated the best bolus dose of norepinephrine for management of a maternal hypotensive episode. In this study the investigators will investigate the efficacy and side effects of two doses of norepinephrine bolus doses (6 mcg and 10 mcg) in management of maternal hypotensive episode after subarachnoid block during cesarean delivery.

• Study Type: Interventional
• Enrollment (Anticipated): 86
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11432
    • Recruiting
    • Ahmed Mohamed Hasanin
    • Contact: Ahmed M Hasanin; Phone Number: 1095076954

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• pregnant women
• scheduled for cesarean delivery

Exclusion Criteria:

• patients with severe cardiac dysfunction
• patients with low blood pressure
• patients with ante-partum bleeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Norepinephrine 6 mcg; Mothers in this group will receive a bolus of Norepinephrine 6 mcg for management of hypotensive episode after spinal anesthesia using Bupivacaine hydrochloride under prophylactic Norepinephrine infusion	Drug: Norepinephrine 6 mcg; An intravenous bolus of norepinephrine 6 mcg will be administered for management of maternal hypotension.; Other Names: Levophed; Drug: Bupivacaine Hydrochloride; Subarachnoid block will be performed using Bupivacaine hydrochloride (2.2 mL) in addition to fentanyl 25 mcg; Other Names: Marcaine; Drug: Norepinephrine infusion; Prophylactic norepinephrine infusion will be started after subarachnoid block; Other Names: Levophed
ACTIVE_COMPARATOR: Norepinephrine 10 mcg; Mothers in this group will receive a bolus of Norepinephrine 10 mcg for management of hypotensive episode after spinal anesthesia using Bupivacaine hydrochloride under prophylactic Norepinephrine infusion	Drug: Norepinephrine 10 mcg; An intravenous bolus of norepinephrine 10 mcg will be administered for management of maternal hypotension.; Other Names: Levophed; Drug: Bupivacaine Hydrochloride; Subarachnoid block will be performed using Bupivacaine hydrochloride (2.2 mL) in addition to fentanyl 25 mcg; Other Names: Marcaine; Drug: Norepinephrine infusion; Prophylactic norepinephrine infusion will be started after subarachnoid block; Other Names: Levophed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of successful management of maternal hypotension	number of patients with successful management of maternal hypotensive episode (defined as return of systolic blood pressure to be ≥ 80% of the baseline reading in the next reading 2 minutes after administration of norepinephrine bolus)	30 minutes after spinal anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Umbilical blood acidity	the measure of acidity or alkalinity of any solution on a logarithmic scale on which 7 is neutral, lower values are more acid and higher values more alkaline.	10 minutes after delivery
Rate of successful management of severe maternal hypotension	number of patients with successful management of maternal severe hypotensive episode (defined as systolic blood pressure lower than 60% of the baseline reading in the next reading 2 minutes after administration of norepinephrine bolus)	30 minutes after spinal anesthesia
incidence of reactive hypertension	number of patients with reactive hypertension (defined as systolic blood pressure ≥120% from the baseline reading after administration of norepinephrine bolus)	30 minutes after spinal anesthesia
systolic blood pressure	systolic blood pressure measured in mmHg	90 minutes after spinal anesthesia
heart rate	number of heart beats per minute	90 minutes after spinal block
Apgar score for evaluation of the activity of the fetus	the Apgar score of the fetus which range from 0 to 10. Th minimum value is 0 and the maximum value is 10. The worst value is 0 and the best value is 10	10 minutes
The frequency of vomiting	The number of patients with vomiting	90 minutes after spinal anesthesia

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 21, 2018
• Primary Completion (ANTICIPATED): June 25, 2022
• Study Completion (ANTICIPATED): July 1, 2022

Study Registration Dates

• First Submitted: October 16, 2018
• First Submitted That Met QC Criteria: October 17, 2018
• First Posted (ACTUAL): October 19, 2018

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: Cardiovascular Diseases; Vascular Diseases; Hypotension; 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-71-2018

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