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Low-Dose Remifentanil in Preterm Cesarean Section with General Anesthesia: A Randomized Controlled Trial

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Abstract

Background and Objective

The conventional technique of general anesthesia induction during a Cesarean section involves the use of opioids only after cord clamping. We hypothesized that the use of remifentanil before cord clamping might reduce the use of maternal supplemental anesthetic agents and improve the maternal hemodynamics status and neonatal adaptation of the preterm neonate.

Methods

A phase III, double-blind, randomized, placebo-controlled, hospital-based trial enrolled parturients undergoing a Cesarean section under general anesthesia before 37 weeks of gestation. Block randomization allocated pregnant women to remifentanil or placebo. The primary outcome was the rate of newborns with Apgar scores < 7 at 5 min. Secondary outcomes were maternal hemodynamic parameters, complications of anesthetic induction, use of adjuvant anesthetic agents, neonatal respiratory distress, umbilical cord pH, and lactate levels.

Results

A total of 52/55 participants were analyzed, comprising 27 women in the remifentanil group and 25 in the placebo group. Nine of 27 (33.3%) neonates had an Apgar score < 7 at 5 min in the remifentanil group versus 11/25 (44.0%) in the placebo group (p = 0.45, odds ratio = 0.66, 95 confidence interval 0.20–2.18). The blood cord gases, cognitive, behavior, sensory, sleeping, and feeding scores at 1 and 2 years of corrected age were not different. For the mothers, hemodynamic parameters, anesthesia duration, and the cumulative treatment dose until cord clamping did not differ between the groups.

Conclusions

The use of a low dose of remifentanil before cord clamping for a Cesarean section appears to be safe both for the mother and the preterm newborn, but it does not improve maternal or neonatal outcomes.

Clinical Trial Registration

ClinicalTrials.gov: NCT02029898.

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Author information

Authors and Affiliations

  1. Service de NéonatoloDepartment of Neonatal Pediatrics, Trousseau Hospital, APHP, Sorbonne Université, 26 Av. du Dr Arnold Netter, 75012, Paris, France

    Clément Chollat

  2. Université Paris Cité, Inserm, NeuroDiderot, 48 boulevard Sérurier, 75019, Paris, France

    Clément Chollat

  3. Clinique de l’Europe, 73, boulevard de l’Europe, 76100, Rouen, France

    Fabien Tourrel

  4. Department of Biostatistics, CHU Rouen, 37 boulevard Gambetta, 76000, Rouen, France

    Estelle Houivet

  5. Department of Anesthesiology and Critical Care, CHU Rouen, 37 boulevard Gambetta, 76000, Rouen, France

    Romain Gillet & Vincent Compère

  6. Department of Obstetrics and Gynaecology, Rouen University Hospital, 37 boulevard Gambetta, 76000, Rouen, France

    Eric Verspyck

  7. Normandie University, UNIROUEN, INSERM U1245, Normandy Centre for Genomic and Personalized Medicine, 22 boulevard Gambetta, 76000, Rouen, France

    Eric Verspyck, Maryline Lecointre & Stéphane Marret

  8. Department of Neonatal Pediatrics and Intensive Care, Rouen University Hospital, 37 boulevard Gambetta, 76000, Rouen, France

    Stéphane Marret

Authors
  1. Clément Chollat
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  2. Fabien Tourrel
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  4. Romain Gillet
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  6. Maryline Lecointre
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  7. Stéphane Marret
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  8. Vincent Compère
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Corresponding author

Correspondence to Clément Chollat.

Ethics declarations

Funding

This study was funded by Société Française d’Anesthésie et Réanimation and Centre Hospitalier Universitaire Rouen. The sponsors had no role in the design and conduct of the study, collection, analysis, and interpretation of result as well as the submission process.

Conflict of Interest

Clément Chollat, Fabien Tourrel, Estelle Houivet, Romain Gillet, Eric Verspyck, Maryline Lecointre, Stéphane Marret, and Vincent Compère have no conflicts of interest that are directly relevant to the content of this article.

Ethics Approval

This study protocol was reviewed and approved by the Ethics Committee of Rouen, France (Comité de Protection des Personnes Nord-Ouest I, approval number 01/015/2013) and registered at ClinicalTrials.gov (NCT02029898, EudraCT 2013-001850-83, primary investigator: Fabien Tourrel, date of registration, 8 January, 2014).

Consent to Participate

Written informed consent was obtained from the participants by the research team before randomization.

Data Availability

The data that support the findings of this study are available on request from the corresponding author.

Code Availability

Not applicable.

Author Contributions

CC and FT conceptualized and designed the study, coordinated and supervised the intervention, collected the data, and participated in manuscript writing and editing. EH carried out the power analyses and participated in manuscript editing. SM and RG participated in the project conception, data management, manuscript writing, and editing. EV participated in manuscript writing and editing. ML participated in the data collection, data management, and manuscript editing. VC analyzed and interpreted the data and participated in manuscript editing.

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Chollat, C., Tourrel, F., Houivet, E. et al. Low-Dose Remifentanil in Preterm Cesarean Section with General Anesthesia: A Randomized Controlled Trial. Pediatr Drugs 26, 71–81 (2024). https://doi.org/10.1007/s40272-023-00591-w

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  • DOI: https://doi.org/10.1007/s40272-023-00591-w

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