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OpenTrials
Completed

NCT Number: NCT05218551

Comparison of Different Objective Nociceptive Measurement Methods During 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sahlgrenska University hospital

Gothenburg, 41310, Sweden

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. An index will be observed 0-100 and hemodynamic response, heart rate and blood pressure.

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

    Data collect only numbers. These are going to be correlated.

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 1, 2022
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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