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Epinephrine Infusion for Prophylaxis Against Maternal Hypotension During Cesarean Delivery

Primary Purpose

Postspinal Hypotension, Cesarean Delivery, Epinephrine

Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Epinephrine 0.03
Epinephrin 0.02
Epinephrin 0.01
Sponsored by
Kasr El Aini Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postspinal Hypotension

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • full-term singleton pregnant women
  • American society of anesthesiologist-physical status I or II,
  • scheduled for elective cesarean delivery

Exclusion Criteria:

  • Patients with uncontrolled cardiac morbidities (patients with tight valvular lesion, impaired contractility with ejection fraction < 50%, heart block, and arrhythmias),
  • hypertensive disorders of pregnancy,
  • peripartum bleeding,
  • coagulation disorders (patients with INR >1.4 and or platelet count < 80000 /dL) or
  • any contraindication to regional anesthesia,
  • and baseline systolic blood pressure (SBP) < 100 mmHg

Sites / Locations

  • Kasr Alaini HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

0.03 mcg group

0.02 mcg group

0.01 mcg group

Arm Description

epinephrine infusion will be started after subarachnoid block until 5 minutes after delivery of the baby

epinephrine infusion will be started after subarachnoid block until 5 minutes after delivery of the baby

epinephrine infusion will be started after subarachnoid block until 5 minutes after delivery of the baby

Outcomes

Primary Outcome Measures

incidence of postspinal hypotension
systolic blood pressure ≤80% of the baseline reading

Secondary Outcome Measures

incidence of tachycardia
heart rate > 130% of baseline
incidence of hypertension
systolic blood pressure >120% of baseline
incidence of severe hypotension
systolic blood pressure ≤60% of the baseline reading
mean heart rate
beat per minute
mean systolic blood pressure
mmHg
total ephedrine requirement
mg
total atropine requirement
mg
Apgar score
Breathing effort Heart rate Muscle tone Reflexes Skin color Each category is scored with 0, 1, or 2, depending on the observed condition
umbilical blood pH
pH
umbilical blood PCO2
mmHg
umbilical blood PO2
mmHg
umbilical blood HCO3
mmol/L

Full Information

First Posted
February 23, 2022
Last Updated
August 25, 2022
Sponsor
Kasr El Aini Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05279703
Brief Title
Epinephrine Infusion for Prophylaxis Against Maternal Hypotension During Cesarean Delivery
Official Title
The Use of Epinephrine Infusion for Prophylaxis Against Maternal Hypotension During Cesarean Delivery: a Randomized Controlled Dose-finding Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2022 (Actual)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Maternal hypotension after spinal block is a common complication after subarachnoid block in this population. The incidence of maternal hypotension is nearly 60% when prophylactic vasopressors are not used. Therefore, it is highly recommended to use vasopressors, preferably as continuous infusion, for prophylaxis rather than delaying their use until hypotension occurs. Phenylephrine (PE) is the recommended drug for prophylaxis against hypotension during cesarean delivery; however, the use of PE is commonly associated with decreased heart rate and probably cardiac output because PE is a pure alpha adrenoreceptor agonist. Introduction of NE in obstetric practice had shown favorable maternal and neonatal outcomes and was associated with higher heart rate and cardiac output compared to PE. However, there is still some mothers who develop bradycardia and diminished cardiac output with the use of NE. The most desired scenario during hemodynamic management of mothers during cesarean delivery would achieve the least possible incidences of maternal hypotension, bradycardia and reactive hypertension. Therefore, it is warranted to reach a vasopressor regimen with the most stable hemodynamic profile. In the last year, epinephrine was reported for the first time in obstetric practice with acceptable safety on the mother and the fetus. However, there is still lack of data about the most appropriate dose for infusion during cesarean delivery. This study aims to compare three prophylactic infusion rates for epinephrine during cesarean delivery.
Detailed Description
Upon arrival to the operating room, the patient will be in supine position with left uterine displacement using a wedge below the right buttock. Routine monitoring will be applied (electrocardiography, pulse oximetry, and non-invasive blood pressure monitor). An 18G-cannula will be inserted, and the patients will receive 10 mg metoclopramide. Baseline heart rate and systolic blood pressure will be recorded as the average of three consecutive readings with 2-minutes interval. Lactated Ringer's solution will be infused at rate of 15 mL/Kg over 10 minutes as a co-load; spinal anesthesia will be achieved by injecting 10 mg of hyperbaric bupivacaine and 20 mcg fentanyl into the subarachnoid space at L3-L4 or L4-L5 interspace using 25G spinal needle. After subarachnoid block, mothers will be placed in supine position with left-lateral tilt and the vasopressor infusion will be started. 0.01 mcg group 0.02 mcg group 0.03 mcg group The vasopressor infusion will be through the same line as the fluid a three-way stopcock. The vasopressor infusion will be stopped if heart rate became ≥130% of baseline or systolic blood pressure ≥120% of baseline, otherwise the infusion will be stopped 5 minutes after delivery of the baby. Block success will be assessed after 5 minutes from intrathecal injection of local anesthetic; and will be confirmed if sensory block level is at T4. Post-spinal hypotension (defined as systolic blood pressure ≤80% of the baseline reading during the period from intrathecal injection to delivery of the fetus) will be managed by administration of 9 mg of ephedrine Severe post-spinal hypotension (defined as systolic blood pressure ≤60% of the baseline reading during the period from intrathecal injection to delivery of the fetus) will be managed by administration IV ephedrine 15 mg. Reactive hypertension (defined as systolic blood pressure ≥120% of the baseline reading) will be managed by stoppage of the infusion till the next systolic blood pressure reading. The infusion will be then re-started at the half of the initial rate, when systolic blood pressure decreases to be within 20% of the baseline reading. Intraoperative bradycardia (defined as heart rate less than 55 bpm) will be managed by IV atropine bolus (0.5 mg) will be administered. Fluid administration will be continued up to a maximum of 1.5 liters. An oxytocin bolus (0.5 IU) will be delivered over five seconds after delivery the infused at a rate of 2.5 IU/hour.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postspinal Hypotension, Cesarean Delivery, Epinephrine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
276 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
0.03 mcg group
Arm Type
Active Comparator
Arm Description
epinephrine infusion will be started after subarachnoid block until 5 minutes after delivery of the baby
Arm Title
0.02 mcg group
Arm Type
Active Comparator
Arm Description
epinephrine infusion will be started after subarachnoid block until 5 minutes after delivery of the baby
Arm Title
0.01 mcg group
Arm Type
Active Comparator
Arm Description
epinephrine infusion will be started after subarachnoid block until 5 minutes after delivery of the baby
Intervention Type
Drug
Intervention Name(s)
Epinephrine 0.03
Other Intervention Name(s)
adrenaline
Intervention Description
epinephrine infusion rate of 0.03 mcg/kg/min
Intervention Type
Drug
Intervention Name(s)
Epinephrin 0.02
Other Intervention Name(s)
adrenaline
Intervention Description
epinephrine infusion rate of 0.02 mcg/kg/min
Intervention Type
Drug
Intervention Name(s)
Epinephrin 0.01
Other Intervention Name(s)
adrenaline
Intervention Description
epinephrine infusion rate of 0.01 mcg/kg/min
Primary Outcome Measure Information:
Title
incidence of postspinal hypotension
Description
systolic blood pressure ≤80% of the baseline reading
Time Frame
1 minute after subarachnoid injection till 5 minutes after baby delivery
Secondary Outcome Measure Information:
Title
incidence of tachycardia
Description
heart rate > 130% of baseline
Time Frame
1 minute after subarachnoid injection till 5 minutes after baby delivery
Title
incidence of hypertension
Description
systolic blood pressure >120% of baseline
Time Frame
1 minute after subarachnoid injection till 5 minutes after baby delivery
Title
incidence of severe hypotension
Description
systolic blood pressure ≤60% of the baseline reading
Time Frame
1 minute after subarachnoid injection till 5 minutes after baby delivery
Title
mean heart rate
Description
beat per minute
Time Frame
1 minute after subarachnoid injection, every 2 minutes during procedure, till 5 minutes after baby delivery
Title
mean systolic blood pressure
Description
mmHg
Time Frame
1 minute after subarachnoid injection, every 2 minutes during procedure, till 5 minutes after baby delivery
Title
total ephedrine requirement
Description
mg
Time Frame
1 minute after subarachnoid injection till 5 minutes after baby delivery
Title
total atropine requirement
Description
mg
Time Frame
1 minute after subarachnoid injection till 5 minutes after baby delivery
Title
Apgar score
Description
Breathing effort Heart rate Muscle tone Reflexes Skin color Each category is scored with 0, 1, or 2, depending on the observed condition
Time Frame
5 minutes after delivery
Title
umbilical blood pH
Description
pH
Time Frame
5 minutes after delivery
Title
umbilical blood PCO2
Description
mmHg
Time Frame
5 minutes after delivery
Title
umbilical blood PO2
Description
mmHg
Time Frame
5 minutes after delivery
Title
umbilical blood HCO3
Description
mmol/L
Time Frame
5 minutes after delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: full-term singleton pregnant women American society of anesthesiologist-physical status I or II, scheduled for elective cesarean delivery Exclusion Criteria: Patients with uncontrolled cardiac morbidities (patients with tight valvular lesion, impaired contractility with ejection fraction < 50%, heart block, and arrhythmias), hypertensive disorders of pregnancy, peripartum bleeding, coagulation disorders (patients with INR >1.4 and or platelet count < 80000 /dL) or any contraindication to regional anesthesia, and baseline systolic blood pressure (SBP) < 100 mmHg
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ahmed hasanin
Phone
01095076954
Email
ahmedmohamedhasanin@gmail.com
Facility Information:
Facility Name
Kasr Alaini Hospital
City
Cairo
ZIP/Postal Code
11562
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anesthesia, Pain Management and Surgical ICU Department
Phone
00201222224057
Email
Anesthesia.kasralainy@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Available from PI upon reasonable request

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Epinephrine Infusion for Prophylaxis Against Maternal Hypotension During Cesarean Delivery

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