Clinical trial NCT04593550: Electroencephalographic Changes Under General Anesthesia in Patients With Gynecologic Cancers With and Without History of Chemotherapy
Official title: A Pilot Study to Identify Electroencephalographic Changes Under General Anesthesia in Patients With and Without History of Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Female Reproductive System Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2020-10-20
Enrollment: 40
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with gynecologic cancers with or without history of preoperative chemotherapy

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in the amplitude of alpha oscillations 15 minutes after incision
timeFrame: 15 minutes after incision
Secondary outcomes:
measure: Patient State Index (PSI)
timeFrame: Up to 2 days post surgery
measure: Electroencephalography (EEG) power
timeFrame: During surgery
measure: Burst suppression analysis
timeFrame: During surgery
measure: Burst suppression ratio
timeFrame: During surgery
measure: Coherence analysis
timeFrame: During surgery
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Juan P Cata, MD
role: PRINCIPAL_INVESTIGATOR
References: