Clinical trial NCT05248932: Norepinephrine to Prevent Hypotension in Ceasrean Delivery
Official title: Role of Norepinephrine Infusion in Preventing Hypotension During Spinal Anesthesia for Cesarean Delivery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypotension
Cesarean Section Complications
Keywords: hypotension
norepinephrine
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2022-02-21
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: throracic volume variations change from baseline
timeFrame: every 10 minutes up to 1 hour
measure: cardiac index change from baseline
timeFrame: every 10 minutes up to 1 hour
measure: systemic vascular resistance change from baseline
timeFrame: every 10 minutes up to 1 hour
measure: stroke volume variation change from baseline
timeFrame: every 10 minutes and up to 1 hour
Secondary outcomes:
measure: umblical cord gases sample
timeFrame: in the first minute after delivery
measure: APGAR score
timeFrame: after 5 minutes and 10 minutes after delivery
measure: Non invasive MEAN blood pressure
timeFrame: every 10 minutes and up tp 1 hour
measure: Heart rate
timeFrame: every 10 minutes and up to 1 hour
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: Faculty of Medicine, University Hospitals
state: Menoufia
Study officials:
References: