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Epinephrine Infusion for Prophylaxis Against Maternal Hypotension During Caesarean Section

Primary Purpose

Post-spinal Hypotension, Cesarean Section

Status
Terminated
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Epinephrin 0.03
Epinephrin 0.05
Epinephrin 0.07
Sponsored by
Kasr El Aini Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post-spinal Hypotension

Eligibility Criteria

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

Inclusion Criteria:

  • full-term singleton pregnant women
  • American society of anesthesiologist 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)
  • any contraindication to regional anesthesia,
  • baseline systolic blood pressure (SBP) < 100 mmHg will be excluded from the study

Sites / Locations

  • Kasr Alaini Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

epinephrine 0.03 mcg

epinephrine 0.05 mcg

epinephrine 0.07 mcg

Arm Description

Outcomes

Primary Outcome Measures

the incidence of post-spinal hypotension
systolic blood pressure less than 80% of baseline value

Secondary Outcome Measures

the incidence of severe post-spinal hypotension
systolic blood pressure less than 60% of baseline value
the incidence of reactive hypertension
systolic blood pressure more than 120% of baseline value
total ephedrine dose
mg
the incidence of tachycardia
heart rate >130% of baseline value
the incidence of bradycardia
heart rate < 55 bpm
number of physician intervention
stopping or restarting the norepinephrine infusion, or injecting ephedrine or atropine

Full Information

First Posted
September 10, 2021
Last Updated
February 23, 2022
Sponsor
Kasr El Aini Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05051150
Brief Title
Epinephrine Infusion for Prophylaxis Against Maternal Hypotension During Caesarean Section
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
February 2022
Overall Recruitment Status
Terminated
Why Stopped
tachycardia and arrhythmia in the high doses groups 0.05 and 0.07 necessitate stopping the infusion
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
November 1, 2021 (Actual)

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. In this study, we aim 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, and 50 mg ranitidine. 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. To maintain the double-blind scheme, the total dosage of epinephrine (mcg) for patients in each group will be calculated and added to the 50 ml syringe and will be infused at rate of 50 mL/hour. The calculated epinephrine dose will be withdrawn using insulin syringe. The vasopressor infusion will be through the same line as the intravenous fluids using a three-way stopcock. the infusion will be stopped when there is tachycardia (>130% of baseline value) and/or reactive hypertension (systolic blood pressure > 120% of baseline), otherwise the infusion will be stopped 5-mins after the baby delivery. 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) will be managed by administration IV ephedrine 15 mg. Reactive hypertension (defined as systolic blood pressure ≥120% from 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
Post-spinal Hypotension, Cesarean Section

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
epinephrine 0.03 mcg
Arm Type
Active Comparator
Arm Title
epinephrine 0.05 mcg
Arm Type
Active Comparator
Arm Title
epinephrine 0.07 mcg
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Epinephrin 0.03
Intervention Description
epinephrine infusion rate of 0.03 mcg/kg/min will start from subarachnoid injection of local anesthetic until 5-min after baby delivery
Intervention Type
Drug
Intervention Name(s)
Epinephrin 0.05
Intervention Description
epinephrine infusion rate of 0.05 mcg/kg/min will start from subarachnoid injection of local anesthetic until 5-min after baby delivery
Intervention Type
Drug
Intervention Name(s)
Epinephrin 0.07
Intervention Description
epinephrine infusion rate of 0.07 mcg/kg/min will start from subarachnoid injection of local anesthetic until 5-min after baby delivery
Primary Outcome Measure Information:
Title
the incidence of post-spinal hypotension
Description
systolic blood pressure less than 80% of baseline value
Time Frame
1 minutes after spinal injection until 5-minutes after the baby delivery
Secondary Outcome Measure Information:
Title
the incidence of severe post-spinal hypotension
Description
systolic blood pressure less than 60% of baseline value
Time Frame
1 minutes after spinal injection until 5-minutes after the baby delivery
Title
the incidence of reactive hypertension
Description
systolic blood pressure more than 120% of baseline value
Time Frame
1 minutes after spinal injection until 5-minutes after the baby delivery
Title
total ephedrine dose
Description
mg
Time Frame
1 minutes after spinal injection until 5-minutes after the baby delivery
Title
the incidence of tachycardia
Description
heart rate >130% of baseline value
Time Frame
1 minutes after spinal injection until 5-minutes after the baby delivery
Title
the incidence of bradycardia
Description
heart rate < 55 bpm
Time Frame
1 minutes after spinal injection until 5-minutes after the baby delivery
Title
number of physician intervention
Description
stopping or restarting the norepinephrine infusion, or injecting ephedrine or atropine
Time Frame
1 minutes after spinal injection until 5-minutes after the baby 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 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) any contraindication to regional anesthesia, baseline systolic blood pressure (SBP) < 100 mmHg will be excluded from the study
Facility Information:
Facility Name
Kasr Alaini Hospital
City
Cairo
ZIP/Postal Code
11562
Country
Egypt

12. IPD Sharing Statement

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Epinephrine Infusion for Prophylaxis Against Maternal Hypotension During Caesarean Section

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