Acute Pain Oscillation in Electroencephalographic Monitoring Under General Anaesthesia

NCT05873894 | Recruiting

• 1 other identifier: 31/2020
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

Chronic pain is an undesirable condition that impacts predominantly quality of life at all levels. Chronic pain might occur in healthy young patients when acute postoperative pain is undertreated and persists in time. There are some indexes in the market to evaluate pain, but they assess mainly parasympathetic activity. Hence, it´s a measure of the physiological response to pain, which is still a not well-defined concept. Patients under General Anesthesia might be experimenting unnoticed pain as there is no direct standard method to measure it in clinical practice. This study aims to detect brain oscillatory activity in the intraoperative setting in four situations; awake-no pain, awake-pain, sleep-no pain, and sleep-pain. Pain can be assessed by studying the local and global dynamics of brain activity. A promising upcoming measure of pain could be implemented in clinical practice to detect and treat pain.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Oscillations related to pain in the EEG

  The main objective is the characterization and evaluation of the neural oscillations in the EEG that occur in the anesthetized patient when acute intraoperative pain occurs during monitoring by neurophysiology in neurosurgery. The current procedure includes patient monitoring with neurophysiology electrodes at muscle level and EEG for proper mapping of the functions to be explored when the patient is under the effects of general anesthesia. To carry out this work, it would be necessary to monitor the EEG with the patient awake, since it is intended to look for the characteristic neural oscillations at the moment in which the second peripheral venous line is cannulated.

  since start of surgery until the end

Secondary Outcomes (2)

• Incidence of Chronic pain

  after surgery until 1 year post surgery

• opiod consumption

  during surgery until 1 year post surgery

Interventions

EEG DEVICE

EEG recordings and analysis. Sensory evoked potentials analysis Motor evoked potentials studies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with anaesthesia and eeg monitoring

You may qualify if:

• Adult patients that undergo schedule neurosurgery with neurophysiological monitorisation.
• American Society of Anaesthesiologist physical status (ASA) I-IV.

You may not qualify if:

• Pregnancy
• Obstructive hydrocephaly with or with a derivative catheter.
• Patients with neurostimulator
• Emergency surgery.

Sponsors & Collaborators

• Hospital General Universitario de Valencia: lead

Study Sites (2)

CHGUV

Valencia, 46014, Spain

RECRUITING

CHGUV

Valencia, Spain

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Central Study Contacts

Carolina S Romero, PhD

CONTACT

+34963187554; romero_carolinasol@gva.es

Paula Solis, MD

CONTACT

paulasolisalbamonte@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: May 24, 2023
• Study Start: May 15, 2023
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): December 15, 2028
• Last Updated: July 24, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)