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)

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) - REAGI

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001850-83-FR

Enrollment

Registered

2015-09-24

Start date

2013-08-02

Completion date

Unknown

Last updated

2021-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pregnant woman older than 18 years with an indication for caesarean section under general anesthesia in a context of prematurity. MedDRA version: 18.0 Level: HLGT Classification code 10026908 Term: Maternal complications of pregnancy System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions

Interventions

Trade Name: ultiva Pharmaceutical Form: Powder for solution for injection Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use

Eligibility

Sex/Gender

All

Inclusion criteria

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 (=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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. - Evaluate the frequency of use of adjuvant anesthetic agents before cord clamping. - 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: Apgar Score value below 7 after 5 minutes calculated in the delivery room by the team supporting the child (midwives or pediatric). ;Timepoint(s) of evaluation of this end point: Primary end point is evaluated at 5 min	—

Measure

Time frame

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. - Evaluate the frequency of use of adjuvant anesthetic agents before cord clamping. - 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: Apgar Score value below 7 after 5 minutes calculated in the delivery room by the team supporting the child (midwives or pediatric). ;Timepoint(s) of evaluation of this end point: Primary end point is evaluated at 5 min

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Secondary

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

Measure

Time frame

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

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Countries

France

Contacts

Public ContactSouplet Fizet Laetitia

CHU- Hôpitaux de Rouen

laetitia.souplet-fizet@chu-rouen.fr+33232888265

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026