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

• ClinicalTrials.gov Identifier: NCT04593550
• Recruitment Status: Recruiting
• First Posted: October 20, 2020
• Last Update Posted: February 2, 2022
• Sponsor: M.D. Anderson Cancer Center
• Information provided by (Responsible Party): M.D. Anderson Cancer Center

Study Description

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.

Condition or disease	Intervention/treatment
Malignant Female Reproductive System Neoplasm	Procedure: Biospecimen Collection; Behavioral: BrainCheck Cognitive Assessment; Procedure: Cognitive Assessment; Procedure: Electroencephalography

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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 40 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Pilot Study to Identify Electroencephalographic Changes Under General Anesthesia in Patients With and Without History of Chemotherapy
• Actual Study Start Date: July 31, 2020
• Estimated Primary Completion Date: December 31, 2022
• Estimated Study Completion Date: December 31, 2022

Groups and Cohorts

Group/Cohort

Intervention/treatment

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.

Procedure: Biospecimen Collection; Undergo collection of blood samples; Behavioral: BrainCheck Cognitive Assessment; Undergo cognitive function assessment BrainCheck; Other Name: BrainCheck; Procedure: Cognitive Assessment; Undergo 3D-Confusion assessment; Procedure: Electroencephalography; Undergo EEG; Other Names: EEG; electroencephalogram

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 60 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients with gynecologic cancers with or without history of preoperative chemotherapy

Criteria

Inclusion Criteria:

• Patients with or without neoadjuvant systemic chemotherapy within 3 months prior surgery.
• Patients with gynecologic cancers undergoing exploratory laparotomy admitted 24 hours or longer to the hospital
• American Society of Anesthesiologists (ASA) physical status 1-3
• Signed written inform consent

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

Contacts and Locations

Locations

United States, Texas

M D Anderson Cancer Center; Recruiting

Houston, Texas, United States, 77030

Contact: Juan P. Cata 713-792-7452 jcata@mdanderson.org

Principal Investigator: Juan P. Cata

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

• Principal Investigator: Juan P Cata; M.D. Anderson Cancer Center

More Information

Additional Information:

M D Anderson Cancer Center 

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT04593550
• Other Study ID Numbers: 2019-1120; NCI-2020-06076 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); 2019-1120 ( Other Identifier: M D Anderson Cancer Center )
• First Posted: October 20, 2020
• Last Update Posted: February 2, 2022
• Last Verified: January 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms