Comparison of Different Objective Nociceptive Measurement Methods During Surgery

Comparison of Different Objective Nociceptive Measurement Methods During General Anesthesia or Sedation Under Surgery

Traditionally, hemodynamic response e.g. pulse and blood pressure are used to evaluate pain in humans who are anesthetized. These values, however, can be affected by factors other than pain response . In this observational study, different types of digital methods are used that can distinguish signs of pain. However, the study aim to collect data and correlate in between different methods to ensure its reliability.

Study Overview

• Status: Recruiting
• Conditions: Nociceptive Pain

Detailed Description

In humans who undergoing anesthesia or only receiving sedation with the addition of painkillers medication under surgery. Nociceptive response usually treats on the basis of hemodynamic and/or respiratory changes. These are interpreted together with a number of other parameters. The anesthetist can't be totally sure if it is nociceptive response or to light anesthesia given. Today, there are new monitors included techniques for measuring pain (nociception), but these are not used routinely.

By put sensors (adhesive patches) on the skin and connect to these new devices perhaps the anesthetist can be more sure what stimuli patient are responding from, pain or light anesthesia.

These techniques measure muscle activity including sweat gland which have been shown in other research studies demonstrate a higher accuracy regarding the response to nociception. The parameters are presented on a monitor as a value, 0-10 or 0-100. This research study is an observational study and intends to observe values / figures that arise from two different types of commercial monitors and manufactures. After the anesthesia, these values will be compared and evaluated in resect as well to hemodynamic response and in between monitors. The two techniques have never before been studied simultaneously on the same human been (control).

• Study Type: Observational
• Enrollment (Estimated): 75

Contacts and Locations

• Study Contact: Name: pether Jildenstål, Prof.; Phone Number: 0046317866044; Email: pether.jildenstal@gu.se

Study Locations

• Sweden
  • Gothenburg, Sweden, 41310
    • Recruiting
    • Sahlgrenska University Hospital
    • Contact: Pether Jildenstål, PhD/ prof.; Phone Number: 0046317866044; Email: pether.jildenstal@gu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

° Patients over 18 yrs old, who will be anesthetized or sedated under intervention surgery or surgery.

Description

Inclusion Criteria:

• All patients over 18 yrs old,
• Patients who will be anesthetized or sedated under intervention surgery or surgery

Exclusion Criteria:

• Not speaking Swedish
• Neuro cognitive diorders e.g. dementia or can't respond on information given.
• Chronic pain
• Acute brain trauma
• Pregnancy

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
An index will be observed 0-100 and hemodynamic response, heart rate and blood pressure.	Data collect only numbers. These are going to be correlated.	numbers will be collected every minute during the surgery often 1 hour

Collaborators and Investigators

• Sponsor: Göteborg University
• Investigators: Study Director: Pether Jildenstål, Prof., Göteborg University

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2022
• Primary Completion (Estimated): October 30, 2024
• Study Completion (Estimated): November 15, 2024

Study Registration Dates

• First Submitted: January 15, 2022
• First Submitted That Met QC Criteria: January 30, 2022
• First Posted (Actual): February 1, 2022

Study Record Updates

• Last Update Posted (Actual): February 2, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nociceptive Pain
• Other Study ID Numbers: 2021-03692

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No