- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04593550
Electroencephalographic Changes Under General Anesthesia in Patients With Gynecologic Cancers With and Without History of Chemotherapy
A Pilot Study to Identify Electroencephalographic Changes Under General Anesthesia in Patients With and Without History of Chemotherapy
Study Overview
Status
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Texas
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Houston, Texas, United States, 77030
- M D Anderson Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
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.
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Undergo collection of blood samples
Undergo EEG
Other Names:
Undergo cognitive function assessment BrainCheck
Other Names:
Undergo 3D-Confusion assessment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in the amplitude of alpha oscillations 15 minutes after incision
Time Frame: 15 minutes after incision
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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
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15 minutes after incision
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Up to 2 days post surgery
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Electroencephalography (EEG) power
Time Frame: During surgery
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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.
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During surgery
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Burst suppression analysis
Time Frame: During surgery
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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.
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During surgery
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Burst suppression ratio
Time Frame: During surgery
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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.
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During surgery
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Coherence analysis
Time Frame: During surgery
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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.
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During surgery
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Juan P Cata, MD, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-1120 (Other Identifier: M D Anderson Cancer Center)
- NCI-2020-06076 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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