Electroencephalographic Changes Under General Anesthesia in Patients With Gynecologic Cancers With and Without History of Chemotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-31

Study Completion Date

2023-11-17

Brief Summary

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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.

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Detailed Description

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PRIMARY OBJECTIVE:

I. To assess electroencephalography (EEG) changes of women with and without history of chemotherapy exposure undergoing volatile general anesthesia.

SECONDARY OBJECTIVE:

I. To evaluate if chemotherapy-induced cognitive impairment is associated with an increased sensitivity to general anesthetic agents captured by the patient state index (PSI) and observable in changes in alpha (8-12 H) activity in the frontal regions of the EEG) and other study features such as EEG power, burst suppression analysis, burst suppression ratio, and coherence analysis.

EXPLORATORY OBJECTIVES:

I. To assess the relationship between preoperative cognitive function and electroencephalographic changes under general anesthesia.

II. To assess the relationship between EEG signatures under general anesthesia and postoperative cognitive function.

III. To collect blood specimens for extracting information on serum lipids and cytokines at two different times, before anesthetic induction, and 30 to 60 minutes upon arrival to the postoperative anesthesia care unit.

OUTLINE:

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 twice daily (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.

Conditions

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Malignant Female Reproductive System Neoplasm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational (BrainCheck, 3D-CAM, EEG)

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.

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood samples

BrainCheck Cognitive Assessment

Intervention Type BEHAVIORAL

Undergo cognitive function assessment BrainCheck

Cognitive Assessment

Intervention Type PROCEDURE

Undergo 3D-Confusion assessment

Electroencephalography

Intervention Type PROCEDURE

Undergo EEG

Interventions

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Biospecimen Collection

Undergo collection of blood samples

Intervention Type PROCEDURE

BrainCheck Cognitive Assessment

Undergo cognitive function assessment BrainCheck

Intervention Type BEHAVIORAL

Cognitive Assessment

Undergo 3D-Confusion assessment

Intervention Type PROCEDURE

Electroencephalography

Undergo EEG

Intervention Type PROCEDURE

Other Intervention Names

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BrainCheck EEG electroencephalogram

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No