Electroencephalographic Changes Under General Anesthesia in Patients With Gynecologic Cancers With and Without History of Chemotherapy
Condition: Malignant Female Reproductive System Neoplasm
MeSH terms: Genital Neoplasms, Female
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Biospecimen Collection; BrainCheck Cognitive Assessment; Cognitive Assessment; Electroencephalography
Intervention type(s): Procedure; Behavioral; Procedure; Procedure
Intervention description(s): Undergo collection of blood samples; Undergo cognitive function assessment BrainCheck; Undergo 3D-Confusion assessment; Undergo EEG
Other intervention name(s): BrainCheck; EEG; electroencephalogram
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with gynecologic cancers with or without history of preoperative chemotherapy