Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06512402
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
Epinephrine Vs Norepinephrine Infusion During Caesarean Delivery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Epinephrine Versus Norepinephrine Infusion for Prevention of Maternal Hypotension During Caesarean Delivery a Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Epinephrine is a well-known vasoactive agent in medical practice However its use is obstetric population is still scanty Few studies evaluated the use of epinephrine during Cesarean delivery and a recent randomized controlled dose-finding trial reached an acceptable incidence of hypotension 13 with the use of 003 mcgkgmin as prophylaxis
Being a newly introduced vasoactive agent in obstetric practice it is essential to be adequately compared with other vasopressors using the optimum dosage and appropriate outcomes
There are no data till date comparing epinephrine versus norepinephrine infusion during Cesarean delivery using a composite outcome of hypotension hypertension and bradycardia The aim of this study is to compare epinephrine versus norepinephrine infusion for prophylaxis against post-spinal hypotension during Caesarean delivery
Being a newly introduced vasoactive agent in obstetric practice it is essential to be adequately compared with other vasopressors using the optimum dosage and appropriate outcomes
There are no data till date comparing epinephrine versus norepinephrine infusion during Cesarean delivery using a composite outcome of hypotension hypertension and bradycardia The aim of this study is to compare epinephrine versus norepinephrine infusion for prophylaxis against post-spinal hypotension during Caesarean delivery
Detailed Description:
Upon arrival to the operating room routine monitoring will be applied electrocardiography pulse oximetry and non-invasive blood pressure monitor An 18G-cannula will be inserted and 10 mg metoclopramide and 50 mg ranitidine will be delivered Co-load infusion of lactated Ringers solution will be infused at rate of 15 mLKg over 10 minutes and 10 mg hyperbaric bupivacaine in addition to 20 mcg fentanyl will be injected in 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 will receive the vasopressor infusion according to the allocated study group Block success will be assessed after 5 minutes from injecting local anesthetic into the subarachnoid space using pinprick and will be confirmed if sensory block level is at T4 The vasopressor will be infused in the same line with intravenous fluids using a three-way stopcock The baseline systolic blood pressure reading will be calculated as the average of 3 readings obtained in the supine position with left-uterine displacement at two-minute intervals with a difference of 10
Hemodynamic management in both groups will be as follow
Post-spinal hypotension defined as systolic blood pressure 80 of the baseline reading or systolic blood pressure 90 mmHg during the period from intrathecal injection to delivery of the fetus will be managed by ephedrine 9 mg Severe post-spinal hypotension defined as systolic blood pressure 60 of the baseline reading will be managed by administration of ephedrine 15 mg Reactive hypertension defined as systolic blood pressure 120 from the baseline reading will be managed if persisted 1-reading by stoppage of the infusion till the next systolic blood pressure reading
Intraoperative bradycardia defined as heart rate less than 55 bpm will be managed by stoppage of the vasopressor infusion if not associated with hypotension The infusion will be then re-started in a reduced rate 50 when the heart rate is more than 55 bpm IV atropine bolus 05 mg will be administered if bradycardia persisted despite stoppage of the infusion If accompanied with hypotension bradycardia will be managed by IV bolus of ephedrine 9 mg
Reactive tachycardia heart rate 130 of baseline not related to hypotension or ephedrine infusion will be managed if persisted by stoppage of the infusion The infusion will be then re-started in a reduced rate 50 of the initial dose when heart rate will have decreased to be within 30 of the baseline reading
Fluid administration will be continued up to a maximum of 15 liters After delivery an oxytocin bolus 05 IU will be delivered over five seconds followed by infusion at a rate of 25 IUhour
After subarachnoid block mothers will be placed in supine position with left-lateral tilt and will receive the vasopressor infusion according to the allocated study group Block success will be assessed after 5 minutes from injecting local anesthetic into the subarachnoid space using pinprick and will be confirmed if sensory block level is at T4 The vasopressor will be infused in the same line with intravenous fluids using a three-way stopcock The baseline systolic blood pressure reading will be calculated as the average of 3 readings obtained in the supine position with left-uterine displacement at two-minute intervals with a difference of 10
Hemodynamic management in both groups will be as follow
Post-spinal hypotension defined as systolic blood pressure 80 of the baseline reading or systolic blood pressure 90 mmHg during the period from intrathecal injection to delivery of the fetus will be managed by ephedrine 9 mg Severe post-spinal hypotension defined as systolic blood pressure 60 of the baseline reading will be managed by administration of ephedrine 15 mg Reactive hypertension defined as systolic blood pressure 120 from the baseline reading will be managed if persisted 1-reading by stoppage of the infusion till the next systolic blood pressure reading
Intraoperative bradycardia defined as heart rate less than 55 bpm will be managed by stoppage of the vasopressor infusion if not associated with hypotension The infusion will be then re-started in a reduced rate 50 when the heart rate is more than 55 bpm IV atropine bolus 05 mg will be administered if bradycardia persisted despite stoppage of the infusion If accompanied with hypotension bradycardia will be managed by IV bolus of ephedrine 9 mg
Reactive tachycardia heart rate 130 of baseline not related to hypotension or ephedrine infusion will be managed if persisted by stoppage of the infusion The infusion will be then re-started in a reduced rate 50 of the initial dose when heart rate will have decreased to be within 30 of the baseline reading
Fluid administration will be continued up to a maximum of 15 liters After delivery an oxytocin bolus 05 IU will be delivered over five seconds followed by infusion at a rate of 25 IUhour
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None