Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00379691
Status:
COMPLETED
Last Update Posted:
2007-03-21
First Post:
2006-09-21
Brief Title:
Ideal Dose of Phenylephrine to Treat Low Blood Pressure During Cesarean Section
Sponsor:
Samuel Lunenfeld Research Institute Mount Sinai Hospital
Organization:
Samuel Lunenfeld Research Institute Mount Sinai Hospital
Study Overview
Official Title:
Phenylephrine Dose-Finding Study to Minimize Hypotension Due to Spinal Anesthesia for Cesarean Section
Status:
COMPLETED
Status Verified Date:
2007-03
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:
The purpose of this study is to determine the minimum effective bolus dose of phenylephrine to prevent post-spinal hypotension in Cesarean section in 95 of our patients An adequate response will be defined as the absence of hypotension or nauseavomiting during the period from induction of spinal anesthesia to uterine incision prior to fetal delivery
Detailed Description:
The purpose of this study is to determine the minimum effective bolus dose of phenylephrine to prevent post-spinal hypotension in CS in 95 of our patients The study will be conducted in a randomized double-blinded fashion This dose-response study will be conducted as per the up-down sequential allocation method modified by the Narayana rule designed to cluster the results around the ED95
Blood pressure will be monitored every minute from intrathecal injection to the delivery of the child Phenylephrine will be administered every time the blood pressure is equal to or lower than the control valueHypotension will be defined as a SBP less than 80 of the baseline value in which case the treatment will be a failure Hypertension will be defined as a SBP more than 120 of baseline value If a patient presents hypertension for two consecutive measurements the case will be considered a drop outAn adequate response will be defined as the absence of hypotension or nauseavomiting during the period from induction of spinal anesthesia to uterine incision prior to fetal delivery
The results of this study will define the minimum effective dose of phenylephrine to prevent post-spinal hypotension and nauseavomiting secondary to hypotension in Cesarean section thus optimizing the safety profile with respect to maternal and fetal side effects of this vasopressor
Blood pressure will be monitored every minute from intrathecal injection to the delivery of the child Phenylephrine will be administered every time the blood pressure is equal to or lower than the control valueHypotension will be defined as a SBP less than 80 of the baseline value in which case the treatment will be a failure Hypertension will be defined as a SBP more than 120 of baseline value If a patient presents hypertension for two consecutive measurements the case will be considered a drop outAn adequate response will be defined as the absence of hypotension or nauseavomiting during the period from induction of spinal anesthesia to uterine incision prior to fetal delivery
The results of this study will define the minimum effective dose of phenylephrine to prevent post-spinal hypotension and nauseavomiting secondary to hypotension in Cesarean section thus optimizing the safety profile with respect to maternal and fetal side effects of this vasopressor
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-0186-E | None | None | None |