Influence of Nociception Level Monitor (NOL) Guided Analgesic Delivery on Robot-assisted Colorectal Surgery

Last updated: February 13, 2025
Sponsor: University of Southern Denmark
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Standard care

Nociception Level monitor (NOL)

Clinical Study ID

NCT05662371
SHS-An-3-2022
  • Ages 18-80
  • All Genders

Study Summary

Being relatively new, the NOL monitor may offer interesting observations in perioperative nociception levels and appropriate analgesic consumption in diverse surgeries, including robot-assisted surgery. These observations may supplement the current efforts towards further advantages in rapid restitution. Therefore, the investigators planned a trial where intra-operative analgesics were guided using an NOL monitor to study if intra-operative NOL guidance influences peri-operative analgesic consumption, postoperative length of stay and quality of recovery of patients subjected for robot-assisted surgery.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • American Society of Anaesthesiologists score III-IV

  • Scheduled for elective major robot-assisted colorectal surgeries

Exclusion

Exclusion Criteria:

  • Inability to give informed consent

  • planned spinal or epidural anaesthesia

  • all forms of regional anaesthesia, including wound infiltration

  • nonelective procedures

  • pregnancy or lactation

  • atrial fibrillation

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Standard care
Phase:
Study Start date:
August 01, 2023
Estimated Completion Date:
December 31, 2025

Study Description

During anesthesia for surgical procedures, anesthetic and muscle relaxant drugs can be meticulously administered using Bispectral Index (BIS) and neuromuscular monitors. However, analgesic drugs are still dispensed using poor surrogate parameters such as heart rate and blood pressure. This subjective dosing of analgesic drugs may invariably lead to inappropriate intra-operative consumption. This may result in tachycardia, hypertension, and postoperative pain due to e.g. insufficient analgesia, or hypotension, bradycardia, respiratory depression and Post-Operative Nausea and Vomiting (PONV) secondary to excessive analgesia. These effects may be detrimental to the patients especially those with multiple comorbidities with limited vital organ reserves such as patients classified to III or IV by the American Society of Anaesthesia classification (ASA) Similarly, immediate postoperative recovery may also get delayed due to pain, unstable hemodynamics, nausea and vomiting. In that context, there has long been search for a monitor which can guide meticulous administration of analgesics. Recently, a Nociception Level monitor (NOL) based on advanced software algorithms using multiple physiological parameters has been developed. It offers an objective score (NOL Index) which relates to the level of intra-operative pain. NOL technology has been validated and found superior to existing pain indicators in peer-reviewed publications. The NOL monitor may offer interesting observations in perioperative nociception levels and appropriate analgesic consumption in diverse surgeries, including robot-assisted surgery. These observations may supplement the current efforts towards further advantages in rapid restitution. Therefore, the investigators are planning a trial where intra-operative analgesics are guided using an NOL monitor.

Connect with a study center

  • Anaesthesiology and Intensive Care Research Unit

    Aabenraa,
    Denmark

    Active - Recruiting

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