Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06313320
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-03-06
Brief Title:
Intraoperative Electroencephalographic Biomarkers of Postoperative Pain
Sponsor:
University of Chile
Organization:
University of Chile
Study Overview
Official Title:
Determination of the Association of Intraoperative Nociception Electroencephalographic Biomarkers and Postoperative Pain
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to explore whether specific intraoperative EEG signals brain waves or neuronal electrical activity are associated with the severity of acute postoperative pain
Detailed Description:
This is a prospective minimal-risk observational study to collect and analyze EEG data during intraepidermal electrical stimulation in patients receiving general anesthesia GA for abdominal surgery To collect nociception-related EEG signal during GA the investigators designed a standardized Intraepidermal Electrical Stimulation IES Protocol The intensity of the electrical stimulus will be calibrated to each participant perception pre-surgery with 3 different intensities sensitivity threshold mild-pain threshold and moderate-pain threshold The IES will be administered several times throughout the surgical procedure a At baseline prior to induction of GA b Three minutes after loss of consciousness c Five minutes after fentanyl administration and orotracheal intubation d Five minutes after first incision and every 20 minutes until the end of the surgery and f After surgery ends and before extubation To standardize the anesthesia management as much as possible all patients will be attended by a reduced number of anesthesiologists The hypnosis will be achieved with propofol while analgesia will be mainly achieved with either fentanyl or remifentanil EEG will be recorded with a 32-channel high standard equipment Once the patient arrives to the Post-Anesthesia Care Unit PACU the investigators will record the pain reported by the patient using the Numeric Pain Rating Scale every 15 minutes during the first hour and every 30 minutes until patient is discharged from the PACU Also the investigators will both record opioid administration through the surgery and estimate their effect-site concentration with pharmacokineticpharmacodynamic models Besides the investigators will measure opioid plasmatic concentrations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None