This trial is active, not recruiting.

Conditions cesarean section, anesthesia
Treatments remifentanil, sodium chloride 0,9%
Phase phase 1/phase 2
Sponsor University Hospital, Rouen
Start date February 2014
End date July 2016
Trial size 53 participants
Trial identifier NCT02029898, 2012/175/HP


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose prevention
(Active Comparator)
injectable solution, 0.5 microgramme/Kg for 30 seconds following by a continuous dose of 0.1 microgramme/kg/minute
(Placebo Comparator)
injectable solution 0.9% for the end of surgery
sodium chloride 0,9%

Primary Outcomes

Apgar Score value below 7 after 5 minutes
time frame: 5 minutes afer birth

Secondary Outcomes

Maternal hemodynamic parameters (SBP, DBP, MAP, HR),
time frame: intraoperative
Rate of complications of induction (difficult intubation, inhalation)
time frame: intraoperative
Occurrence of respiratory distress requiring mask ventilation of the newborn
time frame: intraoperative
Intubation rate among newborns
time frame: intraoperative
Rate of the use of adjuvant anesthetic agents
time frame: intraoperative
Umbilical cordon blood pH
time frame: intraoperative

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: Inclusion criteria of the mother: - Patient over 18 years - Single pregnancy with an indication for cesarean section under general anesthesia context of prematurity (<37SA) - Patient informed and written consent for participation in this research signed - Affiliation to social security Inclusion criteria of the child: Parents informed and written consent signed by the father and mother for the participation in this research by the child (unless a parent no longer has parental authority) Exclusion Criteria: Non-inclusion criteria of the mother: - Vaginal Delivery - Mother pathology requiring the use of an opioid during induction - Severe Preeclampsia - More than 14 weeks between the information and the inclusion - Patient under guardianship Non-inclusion criteria of the child: Fetal pathology diagnosed in the prenatal period involving the prognosis of the child

Additional Information

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
Principal investigator TOURREL Fabien, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University Hospital, Rouen.