Effects of Norepinephrine-ephedrine Combination on Maternal Hemodynamics

Sponsor

Yuzuncu Yıl University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03672071

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

44.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to investigate the effect of combined use of Ephedrine and Norepinephrine on maternal hemodynamics in patients undergoing cesarean delivery under spinal anesthesia. Secondary aim of the study is to investigate the effect of this combination on neonatal Apgar score and umbilical cord blood gas values.

Condition or Disease	Intervention/Treatment	Phase
Cesarean	Other: Ephedrine, Noradrenaline ,ephedrine+Noradrenaline)	N/A

Detailed Description

The study will have a double-blind design and will include 90 patients planned for elective cesarean delivery aged 18-45 years with an ASA score of I-II who will be randomized by sealed tender and will be divided into 3 groups with 30 patients each. The exclusion criteria will be as follows: conversion to general anesthesia, an ASA score of III and IV, emergency surgery, hemodynamic instability, maternal cardiac and pulmonary diseases, placenta previa, placental abruption, intrauterine fetal death, expectancy for a syndromic child, intrauterine growth restriction, preeclampsia, a history of allergy to Ephedrine and Norepinephrine, and neonatal intubation after birth due to respiratory distress or other causes. Each patient will undergo physical examination and laboratory testing one day prior to the procedure. On the same day, each patient will be given information about spinal anesthesia and cesarean delivery under spinal anesthesia, and the patients consenting to participate will be included in the study.

Each patient will undergo preoperative examination 30 min prior to the surgery. After establishing intravenous access, crystalloid fluid 10 cc/kg will be injected. The patient will then be transferred to the operating table. Routine monitorization will be performed and preoperative hemodynamic parameters including heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP), and blood oxygen saturation (SpO2) will be recorded for each patient.

Spinal Anesthesia Procedure: After placing the patient in the sitting position and ensuring asepsis and antisepsis, the spinal L3-L4 intercostal space will be palpated and 10 mg 0.05% bupivacaine and 25 microgram fentanyl will be administered using a 25-gauge Quincke needle after viewing the cerebrospinal fluid through the arachnoid space, followed by withdrawal of the needle and administration of pressure dressing. Subsequently, the table will be tilted to the left side by 15 degrees and O2 gas flow will be administered through a nasal cannula at a flow rate of 2 L/min. Following the assessment of dermatomal level, surgical procedure will be initiated.

Throughout the surgical procedure, hemodynamic parameters will be recorded using noninvasive methods every 2 min. If a 20% decrease in any hemodynamic parameter compared to their baseline levels is sustained, necessary interventions will be performed. In the case of hypotension, 5 mg Ephedrine, 5 mg Noradrenaline, and 5 mg Ephedrine + 2.5 mg Noradrenaline i.v. will be administered in Groups E, N, and EN, respectively. On the other hand, surgical details including the total number of vasoactive agent administrations and the length of intervals between administrations, frequency of side effects including nausea, vomiting, discomfort, and headache, Apgar scores at min 1 and 5, umbilical cord blood gas values, duration of surgery, and demographic characteristics (e.g. age, height, weight, parity) will be recorded for each patient and will be used for statistical analysis

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A randomized prospective controlled studyA randomized prospective controlled study

Masking:

Single (Participant)

Primary Purpose:

Other

Official Title:

Effectivity of Combined Use of Ephedrine and Norepinephrine on Maternal Hemodynamics in Patients Undergoing Cesarean Delivery Under Spinal Anesthesia

Anticipated Study Start Date :

Sep 30, 2018

Anticipated Primary Completion Date :

Nov 30, 2018

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: Group E If a 20% decrease in any parameter compared to their baseline levels is sustained, necessary interventions 5 mg Ephedrine i.v. will be administered to patient will be performed. In the case of hypotension,	Other: Ephedrine, Noradrenaline ,ephedrine+Noradrenaline) If a 20% decrease in any hemodynamic parameter compared to their baseline levels is sustained, necessary interventions will be performed. In the case of hypotension, for all groups
Other: Group NE .If a 20% decrease in any parameter compared to their baseline levels is sustained, necessary interventions 5 mg Noradrenaline, i.v. will be administered to patient will be performed. In the case of hypotension,	Other: Ephedrine, Noradrenaline ,ephedrine+Noradrenaline) If a 20% decrease in any hemodynamic parameter compared to their baseline levels is sustained, necessary interventions will be performed. In the case of hypotension, for all groups
Other: Group N . If a 20% decrease in parameter compared to their baseline levels is sustained, necessary interventions mg Ephedrine + 2.5 mg Noradrenaline i.v. will be administered to patient will be performed. In the case of hypotension,	Other: Ephedrine, Noradrenaline ,ephedrine+Noradrenaline) If a 20% decrease in any hemodynamic parameter compared to their baseline levels is sustained, necessary interventions will be performed. In the case of hypotension, for all groups

Arm

Intervention/Treatment

Other: Group E

If a 20% decrease in any parameter compared to their baseline levels is sustained, necessary interventions 5 mg Ephedrine i.v. will be administered to patient will be performed. In the case of hypotension,

Other: Ephedrine, Noradrenaline ,ephedrine+Noradrenaline)

If a 20% decrease in any hemodynamic parameter compared to their baseline levels is sustained, necessary interventions will be performed. In the case of hypotension, for all groups

Other: Group NE

.If a 20% decrease in any parameter compared to their baseline levels is sustained, necessary interventions 5 mg Noradrenaline, i.v. will be administered to patient will be performed. In the case of hypotension,

Other: Ephedrine, Noradrenaline ,ephedrine+Noradrenaline)

If a 20% decrease in any hemodynamic parameter compared to their baseline levels is sustained, necessary interventions will be performed. In the case of hypotension, for all groups

Other: Group N

. If a 20% decrease in parameter compared to their baseline levels is sustained, necessary interventions mg Ephedrine + 2.5 mg Noradrenaline i.v. will be administered to patient will be performed. In the case of hypotension,

Other: Ephedrine, Noradrenaline ,ephedrine+Noradrenaline)

If a 20% decrease in any hemodynamic parameter compared to their baseline levels is sustained, necessary interventions will be performed. In the case of hypotension, for all groups

Outcome Measures

Primary Outcome Measures

systolic arterial blood pressure [during operation]
The maximal aortic pressure following ejection is termed the systolic pressure.Throughout the surgical procedure, it will be recorded using noninvasive methods every 2 minute as mm/Hg
diastolic arterial blood pressure [during operation]
The lowest pressure in the aorta, which occurs just before the ventricle ejects blood into the aorta, is termed the diastolic pressure.Throughout the surgical procedure, it will be recorded using noninvasive methods every 2 minute as mm/Hg

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Term pregnant patients.

Exclusion Criteria:

A maternal cardiac diseases
Pulmonary diseases
Placenta previa
Placental abruption
Intrauterine fetal death
Expectancy for a syndromic child
İntrauterine growth restriction
Preeclampsia

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Celaleddin Soyalp	VAN		Turkey	65080

Sponsors and Collaborators

Yuzuncu Yıl University

Investigators

Principal Investigator: CELALEDDİN SOYALP, Yuzuncu Yil University Dursun Odabas Medical School Anesthesiology a nd Reanimation Department, Van, Turkey