Clinical trial · Observational
Electroencephalographic Changes Under General Anesthesia in Patients With Gynecologic Cancers With and Without History of Chemotherapy
A Pilot Study to Identify Electroencephalographic Changes Under General Anesthesia in Patients With and Without History of Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study compares changes in brain waves in women with gynecologic cancers who have or have not received chemotherapy and who are scheduled to receive surgery as part of their standard care. Electroencephalography is a test that measures brain waves and may help learn if sensitivity to anesthesia is higher in women who have received chemotherapy than women who have not. This study may help researchers learn if receiving chemotherapy before surgery can affect the way the brain responds to anesthesia during and after surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Female Reproductive System Neoplasm | Malignant Female Reproductive System Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| BrainCheck Cognitive Assessment | Behavioral | — | UNRESOLVED |
| Cognitive Assessment | Procedure | — | UNRESOLVED |
| Electroencephalography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational (BrainCheck, 3D-CAM, EEG)
- description
- Patients undergo cognitive function assessment BrainCheck over 10 minutes before surgery, day 1 after surgery, and day 2 after surgery (if patients are still admitted to the hospital) and 3D-confusion assessment over 10 minutes BID on day 1 after surgery and day 2 after surgery (if patients are still admitted to the hospital). Patients also undergo EEG during surgery and collection of blood samples 30-60 minutes after surgery.
- interventionNames
- Procedure: Biospecimen Collection
- Behavioral: BrainCheck Cognitive Assessment
- Procedure: Cognitive Assessment
- Procedure: Electroencephalography
Primary outcomes (1)
- measure
- Difference in the amplitude of alpha oscillations 15 minutes after incision
- timeFrame
- 15 minutes after incision
- description
- Data will be analyzed using descriptive statistics and visualizations of the data to establish patterns of symmetry, skewness, and outliers. Will explore differences in the analysis of the alpha oscillations
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: 1. Written informed consent; 2. Women between 40-60 years of age; with or without history of systemic chemotherapy; 3. American Society of Anesthesiologists physical status (ASA) 1-3; 4. Scheduled surgery: open gynecologic surgery; 5. Able to complete all study questionnaires. Exclusion criteria: 1. Emergency surgery 2. ASA ≥ 4 3. Patients with extra-abdominal metastatic disease 4. Patients unable to complete preoperative and postoperative cognitive tests 5. Non-English-speaking patients
References
Publications (0)
Data not yet available