Evaluating a new model for propofol effects during surgery
the BIS Index Response is Poorly Described by Propofol Effect Site Eleveld's Model After Applying a Perturbation
This study tests a new way to understand how propofol affects consciousness in healthy patients during surgery by comparing brain activity measurements.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Universidad del Desarrollo Academic / other |
| Locations | 1 site (Osorno) |
| Trial ID | NCT06417645 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of the Eleveld pharmacokinetic-pharmacodynamic model of propofol in healthy patients undergoing elective surgery. After a slow induction, patients will receive a fixed infusion of propofol until a specific burst suppression ratio is achieved, allowing researchers to compare predicted and actual brain activity using the BIS index and advanced spectrogram analysis. The goal is to improve the understanding of propofol's effects on consciousness by utilizing more accurate EEG markers rather than relying solely on the BIS index.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 to 60 who are scheduled for elective surgery.
Not a fit: Patients undergoing emergency surgery or those with cognitive impairments or allergies to propofol may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more precise monitoring of anesthesia depth, improving patient safety during surgery.
How similar studies have performed: While the Eleveld model has been previously utilized, this specific approach of integrating advanced EEG analysis with propofol administration is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ASA I-II patients between 18 and 60 years of age, who undergo elective surgery in the central ward of the Hospital Base San José Osorno, Chile. Consecutive patients from the beginning of the study up to 12 months from the admission of the first patient. Exclusion Criteria: * Emergency surgery patient. * Patients with dementia, delirium or altered state of consciousness. * Full stomach or risk of aspiration. * Allergic to propofol.
Where this trial is running
Osorno
- Hospital Base san José de Osorno — Osorno, Chile (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.