Norepinephrine to Prevent Hypotension in Ceasrean Delivery

NCT ID: NCT05248932

Last Updated: 2022-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-20
• Study Completion Date: 2022-06-20

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.

Conditions

Hypotension; Cesarean Section Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

cardiometry

Intervention Type: DEVICE

cardiac output, stroke volume and fluid responsiveness monitoring

Norepinephrine infusion

Intervention Type: DRUG

2.5 microgram/min infusion

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.

Group Type: ACTIVE_COMPARATOR

Norepinephrine bolus

Intervention Type: DRUG

5 microgram bolus therapy

cardiometry

Intervention Type: DEVICE

cardiac output, stroke volume and fluid responsiveness monitoring

Interventions

Norepinephrine bolus

5 microgram bolus therapy

Intervention Type: DRUG

cardiometry

cardiac output, stroke volume and fluid responsiveness monitoring

Intervention Type: DEVICE

Norepinephrine infusion

2.5 microgram/min infusion

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Menoufia University

OTHER

Sponsor Role: lead

Responsible Party

mostafa saieed fahim mansour

lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Medicine, University Hospitals

Shibīn al Kawm, Menoufia, Egypt

Countries

Egypt

Other Identifiers

19919ANET33

Identifier Type: -

Identifier Source: org_study_id