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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-05849 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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Principal investigator departed sponsoring organization
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This phase II trials studies the impact of total intravenous anesthesia (TIVA) following cancer surgery. Surgery and the anesthesia delivered causes physiologic stress and trauma resulting in immune suppression. TIVA is an alternative method of general anesthesia that has several benefits over volatile inhalation agents such as reducing nausea, vomiting, and opioid consumption, and promotes earlier return of bowel function following surgery. In addition, TIVA is less immunosuppressive than inhalational agents and has been shown to decrease cancer cell proliferation, migration, and metastasis formation. Giving TIVA during cancer-directed abdominal surgery may decrease the immunosuppressive state in the peri-surgical period.
PRIMARY OBJECTIVE:
I. To evaluate the impact of anesthetic agent on inflammation and immunosuppression among patients undergoing abdominal cancer surgery.
SECONDARY OBJECTIVE:
I. To determine the impact of anesthetic choice on short-term anesthetic and surgical outcomes.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo surgical resection with TIVA.
ARM II: Patients undergo surgical resection with inhaled volatile anesthetics.
After completion of study treatment, patients are followed up for up to 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (surgical resection with TIVA) | Experimental | Patients undergo surgical resection with TIVA. |
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| Arm II (surgical resection with inhaled volatile anesthetics) | Active Comparator | Patients undergo surgical resection with inhaled volatile anesthetics. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anesthesia Procedure | Procedure | Given TIVA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Impact of Anesthetic Agent on Inflammation and Immunosuppression | All data analysis will use Student's t-test, Chi2 test and multivariable regression analysis using linear mixed model. The incidence of these outcomes will also be associated with NET levels. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of Anesthetic Choice on Short-term Anesthetic and Surgical Outcomes | All data analysis will use Student's t-test, Chi2 test and multivariable regression analysis using linear mixed model. The incidence of these outcomes will also be associated with NET levels. | Up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
Previous identified allergy or hypersensitivity to any component of the study treatment
Allergies to eggs, egg products, soybeans, or soy products
Personal or first degree relative with a history of malignant hyperthermia
Has a known additional malignancy that is expected to require active treatment within two years, or is likely to be life-limiting in the opinion of the treating investigator. Superficial bladder cancer, non-melanoma skin cancers, or low-grade prostate cancer not requiring therapy would not exclude participation in this trial.
Uncontrolled intercurrent illness including, but not limited to: Symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant or lactating females
Major surgery within 2 months before enrollment. Complete healing from major surgery must have occurred 1 month before enrollment. Complete healing from minor surgery (eg, simple excision, tooth extraction) must have occurred at least 7 days before enrollment. Subjects with clinically relevant complications from prior surgery are not eligible.
Prisoner status
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| Name | Affiliation | Role |
|---|---|---|
| Aslam Ejaz, MD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (Surgical Resection With TIVA) | Patients undergo surgical resection with TIVA. Anesthesia Procedure: Given TIVA Resection: Undergo surgical resection |
| FG001 | Arm II (Surgical Resection With Inhaled Volatile Anesthetics) | Patients undergo surgical resection with inhaled volatile anesthetics. General Anesthesia Procedure: Given inhaled volatile anesthetics Resection: Undergo surgical resection |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (Surgical Resection With TIVA) | Patients undergo surgical resection with TIVA. Anesthesia Procedure: Given TIVA Resection: Undergo surgical resection |
| BG001 | Arm II (Surgical Resection With Inhaled Volatile Anesthetics) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Impact of Anesthetic Agent on Inflammation and Immunosuppression | All data analysis will use Student's t-test, Chi2 test and multivariable regression analysis using linear mixed model. The incidence of these outcomes will also be associated with NET levels. | Due to the early termination of the study, only one participant underwent surgery and received treatment and that participant did not stay on study long enough to have data collected for the primary or secondary outcome measure. Therefore, there is no collected data to report for this outcome measure. | Posted | Up to 2 years |
|
From baseline until the study was terminated, an average of 1.5 months for each participant
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I (Surgical Resection With TIVA) | Patients undergo surgical resection with TIVA. Anesthesia Procedure: Given TIVA Resection: Undergo surgical resection |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Aslam Ejaz | The Ohio State University Comprehensive Cancer Center | 614-293-7171 | aejaz@uic.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 17, 2023 | Mar 27, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 17, 2023 | Mar 27, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000768 | Anesthesia, General |
| ID | Term |
|---|---|
| D000760 | Anesthesia and Analgesia |
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| General Anesthesia Procedure | Drug | Given inhaled volatile anesthetics |
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| Resection | Procedure | Undergo surgical resection |
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Patients undergo surgical resection with inhaled volatile anesthetics.
General Anesthesia Procedure: Given inhaled volatile anesthetics
Resection: Undergo surgical resection
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Arm II (Surgical Resection With Inhaled Volatile Anesthetics) |
Patients undergo surgical resection with inhaled volatile anesthetics. General Anesthesia Procedure: Given inhaled volatile anesthetics Resection: Undergo surgical resection |
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| Secondary | Impact of Anesthetic Choice on Short-term Anesthetic and Surgical Outcomes | All data analysis will use Student's t-test, Chi2 test and multivariable regression analysis using linear mixed model. The incidence of these outcomes will also be associated with NET levels. | Due to the early termination of the study, only one participant underwent surgery and received treatment and that participant did not stay on study long enough to have data collected for the primary or secondary outcome measure. Therefore, there is no collected data to report for this outcome measure. | Posted | Up to 2 years |
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|
| 0 |
| 5 |
| 0 |
| 5 |
| 3 |
| 5 |
| EG001 | Arm II (Surgical Resection With Inhaled Volatile Anesthetics) | Patients undergo surgical resection with inhaled volatile anesthetics. General Anesthesia Procedure: Given inhaled volatile anesthetics Resection: Undergo surgical resection | 1 | 3 | 0 | 3 | 2 | 3 |
| Anemia | Blood and lymphatic system disorders | CTCAE v.5.0 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | CTCAE v.5.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | CTCAE v.5.0 | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE v.5.0 | Systematic Assessment |
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| Alkaline phosphatase increased | Investigations | CTCAE v.5.0 | Systematic Assessment |
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| Flank Pain | Musculoskeletal and connective tissue disorders | CTCAE v.5.0 | Systematic Assessment |
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| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | CTCAE v.5.0 | Systematic Assessment |
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| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE v.5.0 | Systematic Assessment |
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| Obstruction gastric | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
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| Peripheral sensory neuropathy | Nervous system disorders | CTCAE v.5.0 | Systematic Assessment |
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| Platelet count decreased | Investigations | CTCAE v.5.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | CTCAE v.5.0 | Systematic Assessment |
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| Gait disturbance | General disorders | CTCAE v.5.0 | Systematic Assessment |
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| Hyperkalemia | Metabolism and nutrition disorders | CTCAE v.5.0 | Systematic Assessment |
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| Hyperphosphatemia | Metabolism and nutrition disorders | CTCAE v.5.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | CTCAE v.5.0 | Systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | CTCAE v.5.0 | Systematic Assessment |
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| Lipase increased | Investigations | CTCAE v.5.0 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE v.5.0 | Systematic Assessment |
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