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

ConditionsOpioid Use, UnspecifiedPain, Postoperative
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Southern Denmark

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

American Society of Anaesthesiologists score III-IV

Scheduled for elective major robot-assisted colorectal surgeries

Disqualifiers

Inability to give informed consent

planned spinal or epidural anaesthesia

all forms of regional anaesthesia, including wound infiltration

nonelective procedures

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nociception Level monitor (NOL)

    Device

    NOL technology uses a multiparameter-based sensor platform, and advanced algorithm, to continuously monitor Autonomic Nervous System (ANS) functions. NOL reflects a patient's nociceptive state and analgesic effect, helping to optimize the administration of systemic and/or regional analgesics, and avoiding overdose or underuse of these drugs. The nociception level is a multiparameter monitor that combines information from the finger photoplethysmogram amplitude, skin conductance, skin conductance fluctuation, heart rate, heart rate variability, and their time derivatives into one index ranging from 0 (absence of noxious stimulation) to 100 (severe noxious stimulation).

  • Standard care

    Device

    Hemodynamic changes outside of the normal range i.e., hypertension (systolic blood pressure greater than 140 mm Hg), tachycardia (heart rate greater than 90 min-1) and hypotension (mean arterial pressure less than 60 mm Hg) will be first assessed using the guidance of Bispectral index and Train of four monitors. Sufentanil in doses of 2.5 to 5 mcg (maximum of 0.6-1.2 mic/kg for the entire surgery) is administered if the Bispectral index and Train of four monitor values are within normal range and if required vasopressor infusion is used. Vasoconstrictors may be given as a continuous infusion of norepinephrine, or bolus doses of ephedrine or phenylephrine. Only when blood pressure remains, low additional crystalloids will be given. Finally, in case of bradycardia (heart rate less than 30 min-1), atropine may be given

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Standard Clinical Care GroupPlacebo comparator 1 intervention
Group B: Nociception Level-guided Analgesia GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Total intraoperative consumption of sufentanil Total intraoperative consumption of sufentanil

Amount of sufentanil in micrograms administered during the entire operative period i.e. from induction of anaesthesia up to transfer to the recovery room

Time frame
From induction of anaesthesia up to transfer to recovery room, up to 6 hours

Secondary outcomes

1

Eligible time to discharge as per RR discharge score

The RR discharge score is a scoring system developed for general surgery by the Danish Society of Anesthesia and Intensive Care. The score consists of 5 semi-objective variables (sedation, respiration, nausea, pain, and motor function) and 5 objective variables (peripheral saturation, diuresis, arterial blood pressure, heart rate and temperature). The nurses score each variable from 0 to 3 points. Low scores( below 3 for 2 consecutive hours) indicate a stable condition, and patients are considered eligible for discharge. The score values at different time points represent the quality of recovery.

Time frame
From admission to recovery room until discharge, up to 24 hours
2

Postoperative Nausea and Vomiting

Complaint from patient about nausea on arrival in recovery room assessed as yes or no

Time frame
From admission to recovery room, up to 24 hours
3

Change in myocardial function

Difference between preoperative and postoperative (24 hours after surgery) Serum Troponin T and brain natriuretic peptide (proPnP) levels

Time frame
Before anaesthesia induction and 24 hours after completion of surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Southern Denmark

Lead sponsor

Source ClinicalTrials.gov
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