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

NCT05662371 | Recruiting

• 1 other identifier: SHS-An-3-2022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Opioid Use, Unspecified; Pain, Postoperative

Keywords

Nociception,; robotic surgery,; opioids,; postoperative recovery

Outcome Measures

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

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

Secondary Outcomes (3)

• Eligible time to discharge as per RR discharge score

  From admission to recovery room until discharge, up to 24 hours

• Postoperative Nausea and Vomiting

  From admission to recovery room, up to 24 hours

• Change in myocardial function

  Before anaesthesia induction and 24 hours after completion of surgery

Study Arms (2)

Standard Clinical Care Group

PLACEBO COMPARATOR

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

Device: Standard care

Nociception Level-guided Analgesia Group

EXPERIMENTAL

In the nociception level-guided group, sufentanil will be administered to maintain a nociception level value between 10 and 25. In case the nociception level values rise greater than 25 for more than 60 s, additional 2.5 microgram sufentanil (if nociception level increase remained less than 45) or 5 micrograms (if nociception level increase greater than 45). Atropine will be administered when heart rate decreases less than 30 min-1. Because the nociception level may be sensitive to such medication, nociception level values will then not used for at least 5 min to guide analgesia, with the exception of norepinephrine as this drug will be given as continuous infusion

Device: Nociception Level monitor (NOL)

Interventions

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).

Nociception Level-guided Analgesia Group

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

Standard Clinical Care Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anaesthesiologists score III-IV
• Scheduled for elective major robot-assisted colorectal surgeries

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (1)

Anaesthesiology and Intensive Care Research Unit

Aabenraa, Denmark

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Thomas Strøm

  Hospital of Southern Denmark - Aabenraa

  STUDY DIRECTOR

Central Study Contacts

Thomas Strøm

CONTACT

+45 79 97 00 00; thomas.strom@rsyd.dk

Rajesh Bhavsar

CONTACT

+45 79 97 00 00; Rajesh.prabhakar.Bhavsar@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: December 22, 2022
• Study Start: August 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 14, 2025

Record last verified: 2025-02

Locations

DK (1)