Ignite Creation Date:
2024-05-06 @ 2:21 AM
Last Modification Date:
2024-10-26 @ 11:17 AM
Study NCT ID:
NCT02029898
Status:
UNKNOWN
Last Update Posted:
2017-08-30
First Post:
2014-01-06
Brief Title:
Remifentanil for General Anesthesia in the Context of Immaturity
Sponsor:
University Hospital Rouen
Organization:
University Hospital Rouen
Study Overview
Official Title:
Adaptation to Neonatal Life After an Anesthetic Protocol Using Remifentanil for General Anesthesia for Caesarean Section in a Context of Prematurity - REAGI Protocol
Status:
UNKNOWN
Status Verified Date:
2017-08
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
REAGI
Brief Summary:
One of the problems during general anesthesia GA for caesarean section is the place of opioid agents Indeed the literature does not provide so far a clear answer regarding the use of opioids prior to extraction of the newborn Indeed if the opioid administration at induction is beneficial for the mother better control of autonomic responses to noxious stimuli the impact on the newborn can be unfavorable in terms of adaptation to extrauterine life This is especially true if the birth takes place in a context of prematurity and or acute fetal distress
The pharmacokinetics of remifentanil make it the only opioid which is consistent with a rapid sequence induction Its short period of action avoids the manual ventilation of patients before intubation while providing a peak of action concomitant to the nociceptive stimulation Patients at high risk of aspiration including pregnant women may benefit from this type of morphine at induction In addition the fact that remifentanil seems to be associated with relative fetal safety in obstetrical or neonatal context legitimized the development of protocols to study maternal-fetal consequences of the use of remifentanil at induction of AG for emergency caesarean section
While cesarean section under general anesthesia mainly concern premature newborns in France no work has focused on the use of remifentanil for caesarean section in a context of preterm without preeclampsia
The main hypothesis of this study is to evaluate the safety of the use of remifentanil in terms of adaptation to extrauterine life in children born prematurely by caesarean section under general anesthesia outside the context of preeclampsia
To do this we will compare two groups of children one consisting of children born by cesarean section under general anesthesia with maternal remifentanil infusion the other made up of children born by cesarean section under general anesthesia without maternal infusion of remifentanil This study is prospective single-center randomized double-blinded
The primary endpoint is formed by the value of the Apgar score less than 7 at 5 minutes calculated in the delivery room by the team supporting the child midwives and pediatricians
The secondary endpoints are formed by maternal hemodynamic parameters SBP DBP MAP HR the rate of complications during induction difficult intubation aspiration the onset of respiratory distress requiring ventilation mask in the newborn the rate of intubation in neonates and the rate of use of adjuvant anesthetic agents
The pharmacokinetics of remifentanil make it the only opioid which is consistent with a rapid sequence induction Its short period of action avoids the manual ventilation of patients before intubation while providing a peak of action concomitant to the nociceptive stimulation Patients at high risk of aspiration including pregnant women may benefit from this type of morphine at induction In addition the fact that remifentanil seems to be associated with relative fetal safety in obstetrical or neonatal context legitimized the development of protocols to study maternal-fetal consequences of the use of remifentanil at induction of AG for emergency caesarean section
While cesarean section under general anesthesia mainly concern premature newborns in France no work has focused on the use of remifentanil for caesarean section in a context of preterm without preeclampsia
The main hypothesis of this study is to evaluate the safety of the use of remifentanil in terms of adaptation to extrauterine life in children born prematurely by caesarean section under general anesthesia outside the context of preeclampsia
To do this we will compare two groups of children one consisting of children born by cesarean section under general anesthesia with maternal remifentanil infusion the other made up of children born by cesarean section under general anesthesia without maternal infusion of remifentanil This study is prospective single-center randomized double-blinded
The primary endpoint is formed by the value of the Apgar score less than 7 at 5 minutes calculated in the delivery room by the team supporting the child midwives and pediatricians
The secondary endpoints are formed by maternal hemodynamic parameters SBP DBP MAP HR the rate of complications during induction difficult intubation aspiration the onset of respiratory distress requiring ventilation mask in the newborn the rate of intubation in neonates and the rate of use of adjuvant anesthetic agents
Detailed Description:
None
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