Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:29 PM
Study NCT ID:
NCT05218551
Status:
COMPLETED
Last Update Posted:
2025-04-06
First Post:
2022-01-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Different Objective Nociceptive Measurement Methods During Surgery
Sponsor:
Göteborg University
Organization:
Study Overview
Official Title:
Comparison of Different Objective Nociceptive Measurement Methods During General Anesthesia or Sedation Under Surgery
Status:
COMPLETED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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).
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: