Norepinephrine to Prevent Hypotension in Ceasrean Delivery

Hypotension Clinical Trial

Official title:

Role of Norepinephrine Infusion in Preventing Hypotension During Spinal Anesthesia for Cesarean Delivery.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05248932
• Other study ID #: 19919ANET33
• Status: Completed
• Phase: Phase 4
• Start date: January 20, 2021
• Est. completion date: June 20, 2022

Study information

• Verified date: October 2022
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will be conducted on 40 healthy women having spinal anesthesia for elective cesarean delivery in the operating rooms at Menoufia university hospital.

Description:

Informed written consent will be taken from all subjects included in the study after approval of the study by the local ethical committee.

All subjects will be subjected to thorough history taking with risk factors, medical histories, general clinical examination, local clinical examination, laboratory investigations as complete blood count and coagulation profile.

Standardized anesthetic care will be provided according to institutional standards, which include fasting, antacid premedication and noninvasive hemodynamic monitoring After arrival in the operating room, patients will be positioned supine with left lateral tilt, pulse oximeter, ECG leads, non-invasive blood pressure cuff and cardiometry leads (4 surface ECG electrodes is attached to the left side of the neck and the lower thorax (approximately at the level of the xiphoid process) will be attached to patient for monitoring of blood pressure (bp), heart rate, fluid responsiveness (thoracic volume variations and stroke volume variations), cardiac index and systemic vascular resistance and values will be recorded as a baseline and every 10 minutes after intrathecal injection.

10 ml/kg/hr lactated ringer solution will be infused to all patients through an 18 gauge intravenous cannula for 30 minutes as a preload before spinal anesthesia then reduced to maintenance infusion of 6 ml/kg/hr.

Patients will be then placed in sitting position. After skin disinfection and skin infiltration with lidocaine 1%, spinal anesthesia will be performed with 2ml 0.5% hyperbaric bupivacaine (10 mg) in addition to 0.5 ml fentanyl (25 μg) at L3-L4 or L4-L5.

The patient will be then returned to the left-tilted supine position. The study drug regimen will be started immediately after intrathecal injection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 20, 2022
• Est. primary completion date: May 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• ASA I & II

• Non laboring

• Normotensive

• Elective cesarean delivery under spinal anesthesia.

• Baseline systolic blood pressure 90-140 mm Hg

Exclusion Criteria:

• Known fetal abnormality.

• Preexisting or pregnancy-induced hypertension.

• Known cardiovascular or cerebrovascular disease.

• Thrombocytopenia, coagulopathy or any contraindication to spinal anesthesia.

• Weight <50 or >100 kg, height <140 or >180 cm.

• Inability or refusal to give informed consent

Related Conditions & MeSH terms

• Cesarean Section Complications
• Hypotension

Intervention

Drug:
• Norepinephrine bolus
5 microgram bolus therapy

Device:
• cardiometry
cardiac output, stroke volume and fluid responsiveness monitoring

Drug:
• Norepinephrine infusion
2.5 microgram/min infusion

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, University Hospitals	Shibin Al Kawm	Menoufia

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	throracic volume variations change from baseline	using cardiometry	every 10 minutes up to 1 hour
Primary	cardiac index change from baseline	using cardiometry	every 10 minutes up to 1 hour
Primary	systemic vascular resistance change from baseline	using cardiometry	every 10 minutes up to 1 hour
Primary	stroke volume variation change from baseline	using cardiometry	every 10 minutes and up to 1 hour
Secondary	umblical cord gases sample		in the first minute after delivery
Secondary	APGAR score	score from 1 to 10 with the highest score better for neonatal outcome	after 5 minutes and 10 minutes after delivery
Secondary	Non invasive MEAN blood pressure	change from baseline	every 10 minutes and up tp 1 hour
Secondary	Heart rate	change from baseline	every 10 minutes and up to 1 hour