Norepinephrine to Prevent Hypotension in Ceasrean Delivery

Menoufia University

Status and phase: Completed; Phase 4

Conditions: Hypotension; Cesarean Section Complications

Treatments: Drug: Norepinephrine infusion; Device: cardiometry; Drug: Norepinephrine bolus

Study type: Interventional

Funder types: Other

Identifiers

NCT05248932

19919ANET33

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

infusion

Active Comparator group

Description:

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

Treatment:

Device: cardiometry

Drug: Norepinephrine infusion

bolus

Active Comparator group

Description:

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.

Treatment:

Device: cardiometry

Drug: Norepinephrine bolus