Comparison of Different Objective Nociceptive Measurement Methods During Surgery

Nociceptive Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05218551
• Other study ID #: 2021-03692
• Status: Recruiting
• Start date: January 2, 2022
• Est. completion date: November 15, 2024

Study information

• Verified date: February 2024
• Source: Göteborg University
• Contact: pether Jildenstål, Prof.
• Phone: 0046317866044
• Email: pether.jildenstal[@]gu.se
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: November 15, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nociceptive Pain

Locations

Country	Name	City	State
Sweden	Sahlgrenska University hospital	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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