Remifentanil for General Anesthesia in the Context of Immaturity

NCT02029898 | Completed Phase 1

• 2 other identifiers: 2012/175/HP2013-001850-83
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Section; Anesthesia

Keywords

cesarean section; anesthesia; children

Outcome Measures

Primary Outcomes (1)

• 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)

  5 minutes afer birth

Secondary Outcomes (6)

• Maternal hemodynamic parameters (SBP, DBP, MAP, HR),

  intraoperative

• Rate of complications of induction (difficult intubation, inhalation)

  intraoperative

• Occurrence of respiratory distress requiring mask ventilation of the newborn

  intraoperative

• Intubation rate among newborns

  intraoperative

• Rate of the use of adjuvant anesthetic agents

  intraoperative

Study Arms (2)

Remifentanil

ACTIVE COMPARATOR

injectable solution, 0.5 microgramme/Kg for 30 seconds following by a continuous dose of 0.1 microgramme/kg/minute

Drug: Remifentanil

Placebo

PLACEBO COMPARATOR

injectable solution 0.9% for the end of surgery

Drug: sodium chloride 0,9%

Interventions

Remifentanil DRUG

Remifentanil

sodium chloride 0,9% DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Vaginal Delivery
• Mother pathology requiring the use of an opioid during induction
• Severe Preeclampsia
• Patient under guardianship
• Fetal pathology diagnosed in the prenatal period involving the prognosis of the child

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

CHU de Rouen

Rouen, 76031, France

Location

Related Publications (1)

• 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.

  PMID: 37713021 DERIVED

MeSH Terms

Interventions

Remifentanil

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• TOURREL Fabien, MD

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2014
• First Posted: January 8, 2014
• Study Start: February 2, 2014
• Primary Completion: June 22, 2018
• Study Completion: June 22, 2018
• Last Updated: March 31, 2026

Record last verified: 2026-01

Locations

FR (1)