Investigating cognitive changes after breast surgery under general anesthesia
Post-Operative Cognitive Dysfunction After Breast Surgery: Incidence and Relation With Common Intraoperative Neuromonitoring Data and Concentration of Propofol and Remifentanil Infused With Targeted Controlled Infusion (TCI )in Women With Laryngeal Mask Airway
University of Padova · NCT03774420
This study is trying to see how breast surgery and the anesthesia used might affect thinking and memory in women after their operation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Padova (other) |
| Locations | 1 site (Treviso, TV) |
| Trial ID | NCT03774420 on ClinicalTrials.gov |
What this trial studies
This observational trial aims to explore the relationship between Post-Operative Cognitive Dysfunction and Emergence Delirium in women undergoing breast surgery. It will assess neurocognitive changes using tests before and after surgery, while also analyzing the concentrations of propofol and remifentanil during anesthesia. The study will utilize intraoperative monitoring values and pupillometry metrics to understand their correlation with cognitive outcomes. The findings could provide insights into the effects of anesthesia on cognitive function in surgical patients.
Who should consider this trial
Good fit: Ideal candidates are women scheduled for breast surgery who will receive general anesthesia with propofol and remifentanil using a laryngeal mask airway.
Not a fit: Patients with neurological pathologies or hemodynamic instability during surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved anesthesia protocols that minimize cognitive dysfunction in patients undergoing breast surgery.
How similar studies have performed: While the specific approach of this study may be novel, previous studies have indicated a relationship between anesthesia and cognitive outcomes, suggesting potential for meaningful findings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * General Anaesthesia delivered with Propofol and Remifentanil with Targeted Controlled Infusion * Use of Laryngeal Mask airway Exclusion Criteria: * Neurological pathologies * Haemodynamical instability during surgery
Where this trial is running
Treviso, TV
- Treviso Regional Hospital — Treviso, TV, Italy (RECRUITING)
Study contacts
- Principal investigator: Federico Linassi, MD — University of Padova
- Study coordinator: Federico Linassi, MD
- Email: federico.linassi@studenti.unipd.it
- Phone: 049 8754256
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.
Conditions: Emergence Delirium, Post-Operative Cognitive Dysfunction, Infusion pumps, Intraoperative brain monitoring