NCT05218551

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2022

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 1, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2024

Completed
Last Updated

April 6, 2025

Status Verified

April 1, 2025

Enrollment Period

2.8 years

First QC Date

January 15, 2022

Last Update Submit

April 3, 2025

Conditions

Nociceptive Pain

Outcome Measures

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.

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University hospital

Gothenburg, 41310, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 39891061DERIVED

MeSH Terms

Conditions

Nociceptive Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pether Jildenstål, Prof.

    Göteborg University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2022

First Posted

February 1, 2022

Study Start

January 2, 2022

Primary Completion

October 30, 2024

Study Completion

November 15, 2024

Last Updated

April 6, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)