CClinicalTrials.gg
CompletedNCT05218551Updated Sep 10, 2026

Comparison of Different Objective Nociceptive Measurement Methods During Surgery

An observational study in Nociceptive Pain, sponsored by Göteborg University. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Göteborg University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Nociceptive Pain

Browse trials for

03

In context

Nociceptive Pain

92 studies on the registry are indexed under Nociceptive Pain; 17 are open to participants now.

This study's enrollment of 50 is below the median of 65 across 28 observational studies indexed under Nociceptive Pain.

Browse Nociceptive Pain studies →

Lead sponsor

Göteborg University is the lead sponsor of 265 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Not speaking Swedish
  • Neuro cognitive diorders e.g. dementia or can't respond on information given.
  • Chronic pain
  • Acute brain trauma
  • Pregnancy
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (actual)
Target follow-up
1 Day
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: numbers will be collected every minute during the surgery often 1 hour

07

Study locations

1 site
  • Sahlgrenska University hospital
    Gothenburg, Gothenburg 41310, Sweden
08

References and documents

Publications

  • Norbeck DW, Lindgren S, Wolf A, Jildenstal P. Reliability of nociceptive monitors vs. standard practice during general anesthesia: a prospective observational study. BMC Anesthesiol. 2025 Jan 31;25(1):51. doi: 10.1186/s12871-025-02923-4. PubMed 39891061 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05218551
Lead sponsor
Göteborg University
Responsible party
Sponsor
First posted
Feb 1, 2022
Start date
Jan 2, 2022
Primary completion
Oct 30, 2024
Completion
Nov 15, 2024
Last update
Sep 10, 2026

Study contacts

Pether Jildenstål, PhD
study director · Göteborg University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion