Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06231316
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-30
First Post:
2024-01-20
Brief Title:
Preventing Hypotension in the Spine During Cesarean Delivery
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Preventing Spinal Hypotension During Cesarean Birth With Two Initial Boluses of Norepinephrine
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Examining the advantages associated with the utilization of noradrenaline in preventing spinal hypotension during cesarean births This involves assessing the positive outcomes and potential benefits derived from incorporating noradrenaline into the medical approach
Detailed Description:
Spinal anesthesia is used during cesarean section to provide rapid onset and dense block of motor and sensory nerves intraoperative analgesia and help patients remain conscious 12Hypotension is common during induction of spinal anesthesia for cesarean delivery CD 3If not promptly treated a decrease in blood pressure BP can have deleterious effects which include maternal nausea vomiting dizziness and cardiovascular instability as well as decreased uteroplacental blood flow with resultant fetal acidosis hypoxia and bradycardiaIn the last decade the α-agonist phenylephrine PE has been the vasopressor of choice for the prevention and treatment of spinal induced hypotension 4To prevent and treat postspinal anesthesia hypotension during cesarean section vasopressors are recommended Vasopressors especially potent α-adrenergic receptor agonists help offset the decrease in arteriolar dilation and peripheral vascular resistance caused by sympathetic nerve blockade after spinal anesthesia and may be associated with decreased incidence of neonatal acidosis56 Norepinephrine is another vasopressor that was recently introduced in obstetric anesthesia 7 Norepinephrine is characterized by α-adrenergic agonistic activity in addition to a weak β-adrenergic agonistic activity thus norepinephrine is considered a vasopressor with minimal cardiac depressant effect7 these pharmacologic properties would make norepinephrine an attractive alternative to phenylephrine and ephedrine in obstetric anesthesia Although the use of norepinephrine for prophylaxis against postspinal hypotension has shown promising results78 evidence is lacking on the optimum dose for norepinephrine infusion during cesarean delivery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None