Nociception Level Index as Monitorization of Pain at the Intensive Care

NCT05762666 | Completed

• 1 other identifier: 212-2022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of our study is to evaluate the effectiveness of a nociception monitor in providing adequate postoperative analgesia for patients needing critical care after surgery. Besides, the study searches to determine the difference between the amount of analgesic medication used when guided by nociception or standard pain management protocols. It is also aimed to reveal the incidence of delirium when pain management is managed under the nociception level index (NOL) guidance. 60 postoperative patients admitted to the postanesthesia care unit (PACU) after general anesthesia for surgery for more than 2 hours will be included and allocated into 2 groups(n=30): the control group (Group A) and the study group (Group B). Group Standard of care will be followed with standard monitorization only along with pain scales and receive rescue analgesia according to them. However, Group NOL will acquire NOL monitorization throughout the ICU stay and have the same rescue analgesia under NOL guidance with concurrent pain scales. Data to be recorded are total postoperative analgesic consumption, NOL values along with CPOT scores, and delirium.

Conditions

Intensive Care, Surgical; Anesthesia, General

Keywords

nociception level index; Postoperative pain; behavioral pain scores; pain monitoring; delirium; postoperative cognitive dysfunction

Outcome Measures

Primary Outcomes (2)

• critical care observation pain tool

  critical care observation pain tool (CPOT) behavioral pain assessment score over 2 is accepted as pain to apply analgesia

  postoperative 24 hour

• number rating scale(NRS)

  number rating scale(NRS) value over 4 is accepted as pain to apply analgesia

  postoperative 24 hour

Secondary Outcomes (3)

• The total amount of analgesic drug

  postoperative 24 hour

• Delirium

  postoperative 24th hour

• cognitive dysfunction

  postoperative 24th hour and postoperative 3th day

Study Arms (2)

Group Standart of care

NO INTERVENTION

Patients will be followed with standard monitorization only along with pain scales and receive rescue analgesia according to them

Group Nociception level index monitor

EXPERIMENTAL

Patients will acquire NOL monitorization throughout the ICU stay and have the same rescue analgesia under NOL guidance with concurrent pain scales

Device: nociception level index monitor

Interventions

nociception level index monitor DEVICE

The nociception level index (NOL) is one of the new electrophysiological devices to asses pain-related nociception and differs with its multi-parameter evaluation. It is generated from five different parameters (heart rate, heart rate variability, skin conductance level, photo-plethysmography waveform amplitude, number of skin conductance fluctuations, and their time derivatives)

Group Nociception level index monitor

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) Physical Status classification I to III
• Patients who have been admitted to the postoperative intensive care unit
• Patients necessitating general anesthesia for surgery of more than 2 hours
• Patients who need mechanical ventilation for a while in intensive care follow-up

You may not qualify if:

• Patients with additional organ failure
• Disease that may make it difficult to wean from the ventilator when lung functions are evaluated (Pao2/fio2 value below 200)
• History of allergies to drugs used in the study protocol
• Patients receiving deep anesthesia with sedation infusion RASS -2 (unable to be awakened by uncooperative audible stimulus)
• Patients with head trauma expected to have a low postoperative Glasgow coma score
• Presence of arrhythmia
• Presence of sepsis during the hospital stay
• Patients who stay more than 48 hours at the postoperative intensive care unit
• Presence of surgical complication
• Known hepatic insufficiency or decreased function
• Known renal insufficiency or decreased function

Sponsors & Collaborators

• Haseki Training and Research Hospital: lead

Study Sites (1)

Haseki Training and Research Hospital

Istanbul, Sultangazi, 34000, Turkey (Türkiye)

Location

Related Publications (3)

• Gelinas C, Shahiri T S, Richard-Lalonde M, Laporta D, Morin JF, Boitor M, Ferland CE, Bourgault P, Richebe P. Exploration of a Multi-Parameter Technology for Pain Assessment in Postoperative Patients After Cardiac Surgery in the Intensive Care Unit: The Nociception Level Index (NOL)TM. J Pain Res. 2021 Dec 7;14:3723-3731. doi: 10.2147/JPR.S332845. eCollection 2021.

  PMID: 34908872 BACKGROUND

• Chanques G, Gelinas C. Monitoring pain in the intensive care unit (ICU). Intensive Care Med. 2022 Oct;48(10):1508-1511. doi: 10.1007/s00134-022-06807-w. Epub 2022 Jul 29. No abstract available.

  PMID: 35904563 RESULT

• Kotfis K, van Diem-Zaal I, Williams Roberson S, Sietnicki M, van den Boogaard M, Shehabi Y, Ely EW. The future of intensive care: delirium should no longer be an issue. Crit Care. 2022 Jul 5;26(1):200. doi: 10.1186/s13054-022-04077-y.

  PMID: 35790979 RESULT

MeSH Terms

Conditions

Pain, Postoperative; Delirium; Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Confusion; Neurobehavioral Manifestations; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cognitive Dysfunction; Cognition Disorders

Study Officials

• Berna Caliskan, MD

  Haseki Training and Research Hospital Anesthesiology and Reanimation Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Data obtained at the clinical follow-up will be gathered by care provider nurses at the ICU who are blind to the study protocol. All evaluations at the surgical wards especially for delirium and cognitive dysfunction will be evaluated by the same independent anesthetist who is blind to the study groups.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Group A will be followed with standard monitorization only along with pain scales and receive rescue analgesia according to them. However, Group B will acquire NOL monitorization throughout the ICU stay and have the same rescue analgesia under NOL guidance with concurrent pain scales.

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: March 9, 2023
• Study Start: January 1, 2023
• Primary Completion: April 30, 2023
• Study Completion: May 30, 2023
• Last Updated: July 10, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)