Cesarean SectionPhase 1/2REAGINCT02029898
Remifentanil for General Anesthesia in the Context of Immaturity
A Phase 1/2 study testing Remifentanil and sodium chloride 0,9% in people with Cesarean Section and Anesthesia, run by University Hospital, Rouen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Section, Anesthesia
- What is being tested?
- Remifentanil and sodium chloride 0,9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteFrance
- Study dates
- 2 Feb 2014to 22 Jun 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
- Conditions
- Cesarean Section, Anesthesia
- Being tested
- Remifentanil, sodium chloride 0,9%
- Keywords
- cesarean section, anesthesia, children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
sodium chloride 0,9%Drug
| Study group | Role | What they receive |
|---|---|---|
| Remifentanil | Active comparator | injectable solution, 0.5 microgramme/Kg for 30 seconds following by a continuous dose of 0.1 microgramme/kg/minute Receives: Drug: Remifentanil |
| Placebo | Placebo comparator | injectable solution 0.9% for the end of surgery Receives: Drug: sodium chloride 0,9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apgar Score value below 7 after 5 minutes
Apgar Score value below 7 after 5 minutes calculated in the delivery room by the team supporting the child (midwives or pediatric)
Measured: 5 minutes afer birth
Secondary outcomes (6)
Maternal hemodynamic parameters (SBP, DBP, MAP, HR),
Measured: intraoperative
Rate of complications of induction (difficult intubation, inhalation)
Measured: intraoperative
Occurrence of respiratory distress requiring mask ventilation of the newborn
Measured: intraoperative
Intubation rate among newborns
Measured: intraoperative
Rate of the use of adjuvant anesthetic agents
Measured: intraoperative
Umbilical cordon blood pH
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study start2 Feb 2014
- Primary completion22 Jun 2018
- Study completion22 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- TOURREL Fabien, MD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02029898
- Sponsor's protocol ID
- 2012/175/HP
- Other IDs
- 2013-001850-83
- Acronym
- REAGI
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2014
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Chollat C, Tourrel F, Houivet E, Gillet R, Verspyck E, Lecointre M, Marret S, Compere V. Low-Dose Remifentanil in Preterm Cesarean Section with General Anesthesia: A Randomized Controlled Trial. Paediatr Drugs. 2024 Jan;26(1):71-81. doi: 10.1007/s40272-023-00591-w. Epub 2023 Sep 15.
PubMed 37713021
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02029898
- Acronym / sponsor ID
- REAGI / 2012/175/HP
- Conditions
- Cesarean Section, Anesthesia
- Keywords
- cesarean section, anesthesia, children
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 2 Feb 2014 (actual)
- Primary completion
- 22 Jun 2018 (actual)
- Study completion
- 22 Jun 2018 (actual)
- First posted
- 8 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remifentanil | Active comparator | Drug: Remifentanilinjectable solution, 0.5 microgramme/Kg for 30 seconds following by a continuous dose of 0.1 microgramme/kg/minute |
| Placebo | Placebo comparator | Drug: sodium chloride 0,9%injectable solution 0.9% for the end of surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remifentanil | Drug | Remifentanil |
| sodium chloride 0,9% | Drug | Placebo |
Primary outcome
Apgar Score value below 7 after 5 minutes
Time frame: 5 minutes afer birth
Apgar Score value below 7 after 5 minutes calculated in the delivery room by the team supporting the child (midwives or pediatric)
6 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Derived from this study: PubMed 37713021Chollat C, Tourrel F, Houivet E, Gillet R, Verspyck E, Lecointre M, Marret S, Compere V. Low-Dose Remifentanil in Preterm Cesarean Section with General Anesthesia: A Randomized Controlled Trial. Paediatr Drugs. 2024 Jan;26(1):71-81. doi: 10.1007/s40272-023-00591-w. Epub 2023 Sep 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TOURREL Fabien, MD principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Remifentanil and sodium chloride 0,9% in people with Cesarean Section and Anesthesia, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apgar Score value below 7 after 5 minutes (time frame: 5 minutes afer birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02029898, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.