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

Malignant Female Reproductive System Neoplasm Clinical Trial

Official title:

A Pilot Study to Identify Electroencephalographic Changes Under General Anesthesia in Patients With and Without History of Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04593550
• Other study ID #: 2019-1120
• Secondary ID: NCI-2020-0607620
• Status: Completed
• Start date: July 31, 2020
• Est. completion date: November 17, 2023

Study information

• Verified date: November 2023
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 17, 2023
• Est. primary completion date: November 17, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Genital Neoplasms, Female
• Malignant Female Reproductive System Neoplasm

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of blood samples

Behavioral:
• BrainCheck Cognitive Assessment
Undergo cognitive function assessment BrainCheck

Procedure:
• Cognitive Assessment
Undergo 3D-Confusion assessment
• Electroencephalography
Undergo EEG

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in the amplitude of alpha oscillations 15 minutes after incision	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	15 minutes after incision
Secondary	Patient State Index (PSI)	For each participant, the PSI will be recorded from the SedLine monitor. Data will be analyzed using descriptive statistics and visualizations of the data to establish patterns of symmetry, skewness, and outliers. PSI will be analyzed between both groups of patients using an independent samples t-test or Wilcoxon's ranksum test, if more appropriate. Chi-square or Fisher's exact tests will be used if study outcomes are categorical. Finally, will also use both Pearson and Spearman's correlation to assess the association between study features such as PSI and cognitive function.	Up to 2 days post surgery
Secondary	Electroencephalography (EEG) power	For each participant, will calculate the slow (0.1-1 Hz), delta (1-4 Hz), theta (4-8 Hz), alpha (8-12 Hz), beta (12-25 Hz), gamma (25-40Hz), and total power (0.1-40Hz). Data will be analyzed using descriptive statistics and visualizations of the data to establish patterns of symmetry, skewness, and outliers. Will explore EEG power between both groups of patients using an independent samples t-test or Wilcoxon's ranksum test, if more appropriate. Chi-square or Fisher's exact tests will be used if study outcomes are categorical. Finally, will also use both Pearson and Spearman's correlation to assess the association between study features such as EEG power and cognitive function.	During surgery
Secondary	Burst suppression analysis	When delivered in a sufficiently high dose, intravenous and volatile anesthetics induce burst suppression. This will be obtained from visual inspection of EEG spectrograms. For each participant, burst suppression will be considered significant if three or more events are observed within 2 min period of stable anesthesia. Data will be analyzed using descriptive statistics and visualizations of the data to establish patterns of symmetry, skewness, and outliers. Will explore burst suppression between both groups of patients using an independent samples t-test or Wilcoxon's ranksum test, if more appropriate. Chi-square or Fisher's exact tests will be used if study outcomes are categorical.	During surgery
Secondary	Burst suppression ratio	Burst suppression ratio is defined as a time domain measure used to track quantitatively the level of burst suppression. It ranges from 0 to 1 and is one of the parameters used to determine depth-of- anesthesia. Data will be analyzed using descriptive statistics and visualizations of the data to establish patterns of symmetry, skewness, and outliers. Will explore burst suppression ratio between both groups of patients using an independent samples t-test or Wilcoxon's ranksum test, if more appropriate. Chi-square or Fisher's exact tests will be used if study outcomes are categorical. Finally, will also use both Pearson and Spearman's correlation to assess the association between study features such as burst suppression ratio for each band and cognitive function.	During surgery
Secondary	Coherence analysis	Will be calculated as a measure of synchrony between two signals at the same frequency as previously described by Purdon et al. Data will be analyzed using descriptive statistics and visualizations of the data to establish patterns of symmetry, skewness, and outliers. Will explore coherence between both groups of patients using an independent samples t-test or Wilcoxon's ranksum test, if more appropriate. Chi-square or Fisher's exact tests will be used if study outcomes are categorical.	During surgery

External Links

•   M D Anderson Cancer Center