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Completed

NCT Number: NCT05248932

Norepinephrine to Prevent Hypotension in Ceasrean Delivery

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

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Medicine, University Hospitals

Shibīn al Kawm, Menoufia, 32511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Norepinephrine bolus

Drug

5 microgram bolus therapy

cardiometry

Device

cardiac output, stroke volume and fluid responsiveness monitoring

Norepinephrine infusion

Drug

2.5 microgram/min infusion

Primary outcomes

  1. throracic volume variations change from baseline

    Time frame: every 10 minutes up to 1 hour

    using cardiometry

  2. cardiac index change from baseline

    Time frame: every 10 minutes up to 1 hour

    using cardiometry

  3. systemic vascular resistance change from baseline

    Time frame: every 10 minutes up to 1 hour

    using cardiometry

  4. stroke volume variation change from baseline

    Time frame: every 10 minutes and up to 1 hour

    using cardiometry

Secondary outcomes

  1. umblical cord gases sample

    Time frame: in the first minute after delivery

  2. APGAR score

    Time frame: after 5 minutes and 10 minutes after delivery

    score from 1 to 10 with the highest score better for neonatal outcome

  3. Non invasive MEAN blood pressure

    Time frame: every 10 minutes and up tp 1 hour

    change from baseline

  4. Heart rate

    Time frame: every 10 minutes and up to 1 hour

    change from baseline

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 21, 2022
Registry last updated
Oct 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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