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

Официальное название

Influence of Nociception Level Monitor (NOL) Guided Analgesic Delivery on the Perioperative Course, Quality of Recovery and Hospital Stay in Robot-assisted Colorectal Surgery

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Nociception Level monitor (NOL)
  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
• Устройство Standard care
  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 an

Первичные конечные точки

• Total intraoperative consumption of sufentanil Total intraoperative consumption of sufentanil [Срок оценки: From induction of anaesthesia up to transfer to recovery room, up to 6 hours]

Вторичные конечные точки (3)

• Eligible time to discharge as per RR discharge score [Срок оценки: From admission to recovery room until discharge, up to 24 hours]
• Postoperative Nausea and Vomiting [Срок оценки: From admission to recovery room, up to 24 hours]
• Change in myocardial function [Срок оценки: Before anaesthesia induction and 24 hours after completion of surgery]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Дания · 1 центр

• Anaesthesiology and Intensive Care Research Unit — Aabenraa

Идентификаторы

NCT: NCT05662371 · SHS-An-3-2022

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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