Determination of the Association of Intraoperative Nociception Electroencephalographic Biomarkers and Postoperative Pain
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pain Postoperative
- Sponsor
- University of Chile
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Maximum Pain in PACU
- Status
- Recruiting
- Last Updated
- last year
Overview
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 pharmacokinetic/pharmacodynamic models. Besides, the investigators will measure opioid plasmatic concentrations.
Investigators
Eligibility Criteria
Inclusion Criteria
- •American Society of Anesthesiologist Performance Status I or II
- •Scheduled for elective laparoscopic abdominal surgery under General Anesthesia
Exclusion Criteria
- •Body Mass Index \> 35 kg/m2
- •Past history or suspected difficult airway
- •Craniofacial malformations
- •Use of regional anesthesia technique during or after the surgery
- •Severe arrhythmia or use of a pacemaker device
- •Severe neuropsychiatric illness (Mayor depression, bipolar disorder, schizophrenia)
- •Regular use of psychoactive drugs
- •Any injury in the right hand
- •Past history of peripheral neuropathy
- •Diabetes Mellitus
Outcomes
Primary Outcomes
Maximum Pain in PACU
Time Frame: From PACU Admission to PACU Discharged, an average of 2 hours
Pain is evaluated several times during PACU stay using the Numeric Rating Scale (from 0 to 10). Discrete Numerical Variable
Secondary Outcomes
- Presence of surgical related pain at day 7(7 days after the surgery (+- 1 day))
- Maximum Pain at 24h(From PACU discharged to 24 hours after PACU discharged)
- Opioid Consumption in PACU(From PACU Admission to PACU Discharged, an average of 72 hours)
- Presence of surgical related pain at day 30(30 days after surgery (+- 3 day))