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Recovery from Anesthesia after Craniotomy for Supratentorial Tumors: Comparison of Propofol-Remifentanil and Sevoflurane-Sufentanil (the PROMIFLUNIL Trial)

Necib, Skander MD*,†; Tubach, Florence MD, PhD†,‡,§; Peuch, Clarisse MD*,†; LeBihan, Eric MD*,†; Samain, Emmanuel MD, PhD∥,¶; Mantz, Jean MD, PhD*,†; Dahmani, Souhayl MD, PhD†,#,**; the PROMIFLUNIL trial group

Journal of Neurosurgical Anesthesiology: January 2014 - Volume 26 - Issue 1 - p 37–44
doi: 10.1097/ANA.0b013e31829cc2d6
Clinical Investigations

Introduction: Rapid recovery after supratentorial tumors (STT) removal is important. Short-acting anesthetics, such as propofol and remifentanil might favor this objective. The aim of this study was to compare the recovery of 2 Bispectral index (BIS)-guided anesthesia protocols combining sevoflurane-sufentanil (SS) or propofol-remifentanil (PR) administered during craniotomy for STT.

Materials and Methods: After IRB approval and written consent, patients scheduled for surgical removal of STT were randomized to receive PR or SS. Anesthesia was adjusted to maintain BIS values between 45 and 55. The primary outcome was the time from discontinuation of anesthetics to extubation. Secondary endpoints were: time to respond to a simple order, and to achieve spontaneous ventilation, agitation score at emergence, postoperative Mini Mental State, postoperative Aldrete score, pain Visual Analogical Score, simplified sedation score, Glasgow Coma Scale, and surgical complications. Statistical analyses were performed using analysis of variance.

Results: Thirty-five and 31 were included in the SS and PR groups, respectively. Times to extubation was not different between the 2 groups (11.8±6.9 vs. 13.0±8.1 min in PR and SS groups, respectively, P=0.577). Although times to achieve an Aldrete score to 10, a Glasgow Coma Scale to 15, and a MMS to 30 significantly were lower in SS group, no significant difference was found when analyzing time course of these 3 factors over the first postoperative day. All other secondary endpoints were not different between the 2 groups.

Conclusion: During craniotomy for STT, we could not demonstrate a reduction in the time to extubation when comparing a BIS-guided anesthesia associating PR to a BIS-guided anesthesia associating SS (Clinicatrials.gov identifier: NCT00389883).

*Department of Anesthesiology, Intensive care and Pain Management, Beaujon University Hospital, Clichy

Department d’Epidémiologie et Recherche Clinique, Paris

Department of Anesthesiology and Intensive Care, University Hospitals of Besançon, Besançon

#Department of Anesthesiology, Intensive Care and Pain Management, Robert Debré University Hospital

Faculté de Médecine Denis DIDEROT (Paris VII), Paris

Faculté de Médecine de Besançon, Besançon

**UMR INSERM U 676, Robert Debré University Hospital

§INSERM, CIE 801, Paris, France

This work was funded and sponsored by the Department of Clinical Research and Development of the Assistance Publique Hôpitaux de Paris.

The authors have no conflicts of interest to disclose.

Reprints: Souhayl Dahmani, MD, PhD, Department of Anesthesiology, Intensive Care and Pain Management, Robert Debré Hospital, 48 Bd Sérurier, 75019 Paris, France (e-mail: souhayl.dahmani@rdb.aphp.fr).

Received November 29, 2012

Accepted May 20, 2013

© 2014 by Lippincott Williams & Wilkins