Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00432991
Status:
COMPLETED
Last Update Posted:
2017-05-22
First Post:
2007-02-07
Brief Title:
Study of the Effect of Intramuscular Ephedrine on the Incidence of Nausea and Vomiting During Elective Cesarean Section
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Study to Evaluate the Effect of Intramuscular Ephedrine on the Incidence of Perioperative Nausea and Vomiting During Elective Cesarean Section
Status:
COMPLETED
Status Verified Date:
2017-04
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 research study is to investigate if the incidence of nausea and vomiting that subjects experience during and after a Cesarean section can be reduced by giving a shot of the drug ephedrine into the thigh muscle at the time of spinal anesthesia administration
Detailed Description:
This research project is designed to study the medication ephedrine when it is given as a routine part of the anesthesia for elective Cesarean section Ephedrine is a medication that is widely used in labor and in vaginal and operative Cesarean section deliveries to help maintain a womans blood pressure within its normal range especially after spinal and epidural anesthesia has been administered The purpose of this study is to determine if ephedrine when given intramuscularly IM as a shot in the muscle at the time of spinal anesthesia administration can help to decrease the incidence of nausea and vomiting subjects experience during and after a Cesarean section This study will compare women who receive ephedrine to a similar group of women who receive a normal saline placebo In addition to looking at the difference in the incidence of nausea and vomiting perioperatively this study will also evaluate if the administration of IM ephedrine helps the baby to receive more blood from the placenta after anesthesia has been administered to the mother This will be evaluated by performing a simple blood test drawn from the umbilical cord after the baby is born
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