Comparison of Vasopressor Boluses for Management of Hypotension After Spinal Anesthesia

NCT ID: NCT03712111

Last Updated: 2021-09-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-21
• Study Completion Date: 2022-07-01

Brief Summary

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.

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.

Conditions

Cesarean Section Complications; Spinal Anesthetic Toxicity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Norepinephrine 6 mcg

Intervention Type: DRUG

An intravenous bolus of norepinephrine 6 mcg will be administered for management of maternal hypotension.

Bupivacaine Hydrochloride

Intervention Type: DRUG

Subarachnoid block will be performed using Bupivacaine hydrochloride (2.2 mL) in addition to fentanyl 25 mcg

Norepinephrine infusion

Intervention Type: DRUG

Prophylactic norepinephrine infusion will be started after subarachnoid block

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

Group Type: ACTIVE_COMPARATOR

Norepinephrine 10 mcg

Intervention Type: DRUG

An intravenous bolus of norepinephrine 10 mcg will be administered for management of maternal hypotension.

Bupivacaine Hydrochloride

Intervention Type: DRUG

Subarachnoid block will be performed using Bupivacaine hydrochloride (2.2 mL) in addition to fentanyl 25 mcg

Norepinephrine infusion

Intervention Type: DRUG

Prophylactic norepinephrine infusion will be started after subarachnoid block

Interventions

Norepinephrine 6 mcg

An intravenous bolus of norepinephrine 6 mcg will be administered for management of maternal hypotension.

Intervention Type: DRUG

Norepinephrine 10 mcg

An intravenous bolus of norepinephrine 10 mcg will be administered for management of maternal hypotension.

Intervention Type: DRUG

Bupivacaine Hydrochloride

Subarachnoid block will be performed using Bupivacaine hydrochloride (2.2 mL) in addition to fentanyl 25 mcg

Intervention Type: DRUG

Norepinephrine infusion

Prophylactic norepinephrine infusion will be started after subarachnoid block

Intervention Type: DRUG

Other Intervention Names

Levophed; Levophed; Marcaine; Levophed

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Hasanin

Assistant professor of anesthesia and critical care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Hasanin, Professor

Role: PRINCIPAL_INVESTIGATOR

Assistant professor of anesthesia

Locations

Ahmed Mohamed Hasanin

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Sarah Amin, Lecturer

Role: CONTACT

sarahamin_22@hotmail.com

+201227476617

Facility Contacts

Ahmed M Hasanin

Role: primary

1095076954

Other Identifiers

N-71-2018

Identifier Type: -

Identifier Source: org_study_id