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Remifentanil for General Anesthesia in the Context of Immaturity (REAGI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02029898
Recruitment Status : Unknown
Verified August 2017 by University Hospital, Rouen.
Recruitment status was:  Active, not recruiting
First Posted : January 8, 2014
Last Update Posted : August 30, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

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.


Condition or disease Intervention/treatment Phase
Cesarean Section Anesthesia Drug: Remifentanil Drug: sodium chloride 0,9% Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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
Study Start Date : February 2014
Actual Primary Completion Date : July 2016
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Active Comparator: Remifentanil
injectable solution, 0.5 microgramme/Kg for 30 seconds following by a continuous dose of 0.1 microgramme/kg/minute
Drug: Remifentanil
Placebo Comparator: Placebo
injectable solution 0.9% for the end of surgery
Drug: sodium chloride 0,9%



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Maternal hemodynamic parameters (SBP, DBP, MAP, HR), [ Time Frame: intraoperative ]
  2. Rate of complications of induction (difficult intubation, inhalation) [ Time Frame: intraoperative ]
  3. Occurrence of respiratory distress requiring mask ventilation of the newborn [ Time Frame: intraoperative ]
  4. Intubation rate among newborns [ Time Frame: intraoperative ]
  5. Rate of the use of adjuvant anesthetic agents [ Time Frame: intraoperative ]
  6. Umbilical cordon blood pH [ Time Frame: intraoperative ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 (<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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02029898


Locations
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France
CHU de Rouen
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
Investigators
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Principal Investigator: TOURREL Fabien, MD CHU de Rouen
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Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT02029898    
Other Study ID Numbers: 2012/175/HP
First Posted: January 8, 2014    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017
Keywords provided by University Hospital, Rouen:
cesarean section
anesthesia
children
Additional relevant MeSH terms:
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Remifentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents