Comparison of Two Norepinephrine Bolus Doses for Management of Post-spinal Hypotension During Cesarean Delivery

Cesarean Section Complications Clinical Trial

Official title:

Norepinephrine for Management of Post-spinal Anesthesia Hypotension During Cesarean Delivery: a Comparison of Two Bolus Doses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03792906
• Other study ID #: N71-2018
• Status: Completed
• Phase: Phase 4
• Start date: January 18, 2019
• Est. completion date: May 1, 2019

Study information

• Verified date: September 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: May 1, 2019
• Est. primary completion date: April 25, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section Complications
• Hypotension
• Spinal Anesthetic Toxicity

Intervention

Drug:
• Norepinephrine 6 mcg
An intravenous bolus of norepinephrine 6 mcg will be administered for management of maternal hypotension.
• Norepinephrine 10 mcg
An intravenous bolus of norepinephrine 10 mcg will be administered for management of maternal hypotension.
• Norepinephrine infusion
Prophylactic norepinephrine infusion will be started after subarachnoid block.
• Bupivacaine hydrochloride
Subarachnoid block will be performed using Bupivacaine hydrochloride (2.2 mL) in addition to fentanyl 25 mcg.

Locations

Country	Name	City	State
Egypt	Ahmed Mohamed Hasanin	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Systolic blood pressure.	Systolic blood pressure measured in mmHg.	2 hours after subarachnoid block
Secondary	Heart rate	Number of heart beats per minute.	2 hours after subarachnoid block
Secondary	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
Secondary	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
Secondary	The frequency of vomiting.	The number of patients with vomiting.	2 hours after subarachnoid block
Secondary	Incidence of bradycardia	number of patients with bradycardia (defined as heart rate less than 55 beat per minute after administration of norepinephrine bolus).	2 hours after subarachnoid block