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

Primary Purpose

Opioid Use, Unspecified, Pain, Postoperative

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nociception Level monitor (NOL)
Standard care
Sponsored by
University of Southern Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Use, Unspecified focused on measuring Nociception,, robotic surgery,, opioids,, postoperative recovery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Standard Clinical Care Group

    Nociception Level-guided Analgesia Group

    Arm Description

    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

    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

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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.
    Postoperative Nausea and Vomiting
    Complaint from patient about nausea on arrival in recovery room assessed as yes or no
    Change in myocardial function
    Difference between preoperative and postoperative (24 hours after surgery) Serum Troponin T and brain natriuretic peptide (proPnP) levels

    Full Information

    First Posted
    December 14, 2022
    Last Updated
    September 28, 2023
    Sponsor
    University of Southern Denmark
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05662371
    Brief Title
    Influence of Nociception Level Monitor (NOL) Guided Analgesic Delivery on Robot-assisted Colorectal Surgery
    Official Title
    Influence of Nociception Level Monitor (NOL) Guided Analgesic Delivery on the Perioperative Course, Quality of Recovery and Hospital Stay in Robot-assisted Colorectal Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2025 (Anticipated)
    Study Completion Date
    December 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Southern Denmark

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Opioid Use, Unspecified, Pain, Postoperative
    Keywords
    Nociception,, robotic surgery,, opioids,, postoperative recovery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard Clinical Care Group
    Arm Type
    Placebo Comparator
    Arm Description
    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
    Arm Title
    Nociception Level-guided Analgesia Group
    Arm Type
    Experimental
    Arm Description
    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
    Intervention Type
    Device
    Intervention Name(s)
    Nociception Level monitor (NOL)
    Intervention Description
    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).
    Intervention Type
    Device
    Intervention Name(s)
    Standard care
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Total intraoperative consumption of sufentanil Total intraoperative consumption of sufentanil
    Description
    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 Outcome Measure Information:
    Title
    Eligible time to discharge as per RR discharge score
    Description
    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
    Title
    Postoperative Nausea and Vomiting
    Description
    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
    Title
    Change in myocardial function
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: American Society of Anaesthesiologists score III-IV Scheduled for elective major robot-assisted colorectal surgeries 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Thomas Strøm
    Phone
    +45 79 97 00 00
    Email
    thomas.strom@rsyd.dk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rajesh Bhavsar
    Phone
    +45 79 97 00 00
    Email
    Rajesh.prabhakar.Bhavsar@rsyd.dk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Thomas Strøm
    Organizational Affiliation
    Hospital of Southern Denmark - Aabenraa
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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