Effect of Vasopressors on Spinal Anaesthesia Induced Hypotension

Last updated: October 22, 2019
Sponsor: Cukurova University
Overall Status: Completed

Phase

4

Condition

Dizzy/fainting Spells

Circulation Disorders

Anesthesia (Local)

Treatment

N/A

Clinical Study ID

NCT03163914
Vasopressor
  • Ages 18-40
  • Female
  • Accepts Healthy Volunteers

Study Summary

160 pregnant patients will be enrolled in this study. Participants will divide in to 4 groups. Spinal anaesthesia will perform with 5% marcain heavy 2 ml+20 microgram fentanyl to the all patients. After performed spinal anaesthesia, vasopressor infusion will be started intravenously. Epinephrine will prepare 5 mg/ml and infusion rate will adjust 30 ml/h for Group E. Norepinephrine will prepare 5 mg/ml and infusion rate will adjust 30 ml/h for Group NE and 0.9% saline (group S) was launched immediately after induction of spinal anesthesia. Phenylephrine will prepare 100 microg/ml and infusion rate will adjust 30 ml/h for Group P. If systolic blood pressure decrease 20% of basal value or below to 100 mmHg, bolus ephedrine will apply intravenously (IV). If heart rate will decrease 60 beat per min or 20% of basal value, atropine will apply IV.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ASA I-II physical status

  • Pregnant patients

  • Full term pregnant

Exclusion

Exclusion Criteria:

  • ASA III-IV physical status

  • Emergency status

  • Heart disease

  • Hypertension

  • Body mass index>25

Study Design

Total Participants: 160
Study Start date:
July 19, 2017
Estimated Completion Date:
April 24, 2018

Study Description

After approved informed consent, 160 pregnant (term) patients with American society of anaesthesiologist (ASA) physiological status I-II will include this prospective, randomized clinical study. For randomisation of participants, computerized randomisation programme will use and they will divide into 4 groups. Basal value of systolic blood pressure(SBP) and heart rate (HR) will calculate with mean of the measure of 3 time SBP and HR before spinal anaesthesia. Spinal anaesthesia will perform with 5% marcain heavy 2 ml+20 microgram fentanyl at the point of lumbar 3-4 or 4-5 interspinous space to the all patients. After performed spinal anaesthesia, vasopressor infusion will start intravenously. Epinephrine, norepinephrine and phenylephrine will use for vasopressor infusion. Epinephrine will prepare 5 mg/ml and infusion rate will adjust 30 ml/h for Group E. Norepinephrine will prepare 5 mg/ml and infusion rate will adjust 30 ml/h for Group NE. Phenylephrine will prepare 100 microg/ml and infusion rate will adjust 30 ml/h for Group P. salin infusion will launch 30 ml/h for group Salin. If systolic blood pressure decrease 20% of basal value or below to 100 mmHg, bolus ephedrine will apply intravenously (IV) for rescue drug. If heart rate will decrease 60 beat per min or 20% of basal value, atropine will apply IV.

At the end of the study all collected data will use for statistically analysis.

Connect with a study center

  • Çukurova University Balcalı Hospital

    Adana, 01380
    Turkey

    Site Not Available

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