Norepinephrine to Prevent Hypotension in Ceasrean Delivery

Phase 4

Completed

• Conditions: Hypotension; Cesarean Section Complications
• Interventions: Device: cardiometry; Drug: Norepinephrine bolus; Drug: Norepinephrine infusion

• Registration Number: NCT05248932
• Lead Sponsor: Menoufia University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-01-20
• Study First Submitted: 2021-12-29
• Study First Submitted QC: 2022-02-09
• Study First Posted: 2022-02-21
• Primary Completion: 2022-05-20
• Study Completion: 2022-06-20
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-12
• Last Update Posted: 2022-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
infusion	cardiometry	patients will receive an infusion of norepinephrine that will be started at 2.5μg/min immediately after intrathecal injection and then manually adjusted according to monitoring of blood pressure (bp), heart rate, fluid responsiveness (thoracic volume variations and stroke volume variations), cardiac index and systemic vascular resistance by using cardiometry, with the objective of maintaining values near baseline
infusion	Norepinephrine infusion	patients will receive an infusion of norepinephrine that will be started at 2.5μg/min immediately after intrathecal injection and then manually adjusted according to monitoring of blood pressure (bp), heart rate, fluid responsiveness (thoracic volume variations and stroke volume variations), cardiac index and systemic vascular resistance by using cardiometry, with the objective of maintaining values near baseline
bolus	Norepinephrine bolus	patient with no prophylactic vasopressor and a bolus of 5 μg norepinephrine will be given whenever systolic BP decreases to \<80% of the baseline value.
bolus	cardiometry	patient with no prophylactic vasopressor and a bolus of 5 μg norepinephrine will be given whenever systolic BP decreases to \<80% of the baseline value.

Primary Outcome Measures

Name	Time	Method
throracic volume variations change from baseline	every 10 minutes up to 1 hour	using cardiometry
cardiac index change from baseline	every 10 minutes up to 1 hour	using cardiometry
systemic vascular resistance change from baseline	every 10 minutes up to 1 hour	using cardiometry
stroke volume variation change from baseline	every 10 minutes and up to 1 hour	using cardiometry

Secondary Outcome Measures

Name	Time	Method
umblical cord gases sample	in the first minute after delivery
APGAR score	after 5 minutes and 10 minutes after delivery	score from 1 to 10 with the highest score better for neonatal outcome
Non invasive MEAN blood pressure	every 10 minutes and up tp 1 hour	change from baseline
Heart rate	every 10 minutes and up to 1 hour	change from baseline

Trial Locations

Locations (1)

Faculty of Medicine, University Hospitals; 🇪🇬 Shibīn Al Kawm, Menoufia, Egypt