Monitoring of nociception by NoL Index and its implication in the reduction of opioid complications in laparoscopic abdominal surgery (SIMONE study): Protocol of a prospective, multicentre, observational cohort study.

Abstract

Background and objectives: Nociception monitoring allows for the titration of opioid drugs in the intraoperative period in order to avoid under- and overdosing of these drugs and their side effects in the patient's postoperative period. For this reason, a study has been designed with the aim of establishing whether the usefulness of the NoL® (Nociception Level) device for adequate intraoperative nociception monitoring can reduce postoperative complications.

Material and methods: Multicentre, observational, prospective cohort study that will include patients who underwent laparoscopic abdominal surgery under balanced general anaesthesia during one year in different hospital centres in order to assess the incidence of early and late postoperative complications and their relationship with the monitoring of nociception studied through the NoL device. Intraoperative pain management will be based on NoL values (visible NoL group) or hemodynamic parameters according to usual clinical practice (non-visible NoL group).

Results: Approval has been obtained from the Autonomous Research Ethics Committee of Aragon (C.I. EPA23/026, 19 April 2023). Simone Studio was registered at www.

Clinicaltrials: gov on 30 May 2024 (Identifier: NCT06437743).

Conclusions: The overall data will be published in peer-reviewed journals. The relevance of the SIMONE study lies in being the first nationwide to comprehensively evaluate opioid dosing, postoperative pain, early and late postoperative complications, and the length of hospital stay. A significant reduction in the incidence of postoperative complications such as nausea and vomiting is expected in the group with visible NoL monitoring.