Adaptation to neonatal life after an anesthetic protocol using remifentanil for general anesthesia for caesarean section in a context of prematurity - REAGI Protocol (Remifentanil for General Anesthesia in the context of Immaturity)

Phase 1

• Conditions: pregnant woman older than 18 years with an indication for caesarean section under general anesthesia in a context of prematurity.; MedDRA version: 18.0Level: HLGTClassification code 10026908Term: Maternal complications of pregnancySystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2013-001850-83-FR
• Lead Sponsor: CHU- Hôpitaux de Rouen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-24
• Last Update Posted: 10 May 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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)
Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Compare the clinical condition of the children born by cesarean section under general anesthesia with remifentanil administration, as assessed by the Apgar score at 5 min, to that of children born by cesarean section under general anesthesia without the use of morphine before clamping the umbilical cord.;Secondary Objective: - Confirm the best haemodynamic control in mothers treated with remifentanil.<br>- Evaluate the frequency of use of adjuvant anesthetic agents before cord clamping.<br>- Confirm the absence of clinical impact of the use of remifentanil in children in the 2 first years of life.;Primary end point(s): Primary endpoint:<br>Apgar Score value below 7 after 5 minutes calculated in the delivery room by the team supporting the child (midwives or pediatric).<br>;Timepoint(s) of evaluation of this end point: Primary end point is evaluated at 5 min

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: All secondary end point(s) are evaluated at Day 0<br>;Secondary end point(s): Secondary endpoints:<br>- Maternal hemodynamic parameters (SBP, DBP, MAP, HR),<br>- Rate of complications of induction (difficult intubation, inhalation)<br>- Occurrence of respiratory distress requiring mask ventilation of the newborn<br>- Intubation rate among newborns<br>- Rate of the use of adjuvant anesthetic agents.