Sevoflurane/fentanyl anesthesia guided by Nociceptive-Level index during abdominal surgery in ASA 1-3 patients – a randomized controlled trial on the effect of NOL-guidance on postoperative pain scores

Inadequate (under-dosing) as well as excessive (overdosing) levels of analgesia and anesthesia are associated with poor patient outcome. Currently, the analgesic component of anesthesia is steered using traditional indices, such as heart rate and blood pressure. However, the use of these indirect parameters for nociception is inaccurate and often results in under- or overdosing of anesthetics. Recently a newly developed index, the Nociceptive Level (NOL) index was validated and showed superiority over heart rate and blood pressure in relation to intense and mild nociceptive stimuli. In this study we will assess the effect of NOL guided anesthesisa (fentanyl/sevoflurane/rocuronium) on postoperative pain and opioid consumption.
Objective
To guide the analgesic component of anesthesia using the NOL index in ASA 1-3 patients under general anesthesia for elective abdominal surgery.

Study design
A randomized, double blinded, controlled trial in which standard care anesthesia and NoL-guided anesthesia will be compared in ASA I-III patients requiring elective abdominal surgery under general anesthesia.

Study population
50 ASA 1-3 patients undergoing elective open abdominal surgery or laparoscopic/ robot-assisted abdominal surgery will.
Main end-points
1. Postoperative pain

Secondary end-points
1. Postoperative opioid consumption
2. Opioid and sevoflurane consumption in total dose and dose/min; and
3. Incidence (number of episodes) of inadequate anesthesia (as derived from heart rate, blood pressure, BIS values)

We hypothesize that, compared with standard management, NoL-guided anesthesia will lead to reduced postoperative pain scores, and during anesthesia to increased hemodynamic stability.

Start June 28, 2019 - End June 28, 2020

This is a double blind, randomized controlled superiority trial in which NOL-guided anesthesia will be compared to standard of care in ASA 1-3 patients undergoing elective open abdominal surgery or laparoscopic assisted abdominal surgery.