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NCT Number: NCT04593550

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

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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Key information

Conditions

Malignant Female Reproductive System Neoplasm

Age range

40 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written informed consent;
  • Women between 40-60 years of age; with or without history of systemic chemotherapy;
  • American Society of Anesthesiologists physical status (ASA) 1-3;
  • Scheduled surgery: open gynecologic surgery;
  • Able to complete all study questionnaires.

Exclusion criteria

  • Emergency surgery
  • ASA ≥ 4
  • Patients with extra-abdominal metastatic disease
  • Patients unable to complete preoperative and postoperative cognitive tests
  • Non-English-speaking patients

Treatment and study plan

Biospecimen Collection

Procedure

Undergo collection of blood samples

BrainCheck Cognitive Assessment

Behavioral

Undergo cognitive function assessment BrainCheck

Other names: BrainCheck

cognitive assessment

Procedure

Undergo 3D-Confusion assessment

electroencephalography

Procedure

Undergo EEG

Other names: EEG, electroencephalogram

Primary outcomes

  1. Difference in the amplitude of alpha oscillations 15 minutes after incision

    Time frame: 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

Secondary outcomes

  1. Patient State Index (PSI)

    Time frame: Up to 2 days post surgery

    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.

  2. Electroencephalography (EEG) power

    Time frame: During surgery

    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.

  3. Burst suppression analysis

    Time frame: During surgery

    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.

  4. Burst suppression ratio

    Time frame: During surgery

    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.

  5. Coherence analysis

    Time frame: During surgery

    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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 20, 2020
Registry last updated
Nov 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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