Trial Outcomes & Findings for Impact of Total Intravenous Anesthesia Following Cancer Surgery, TIVACS Study (NCT NCT04992507)
NCT ID: NCT04992507
Last Updated: 2025-07-10
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2025-07-10
Participant Flow
Participant milestones
| Measure |
Arm I (Surgical Resection With TIVA)
Patients undergo surgical resection with TIVA.
Anesthesia Procedure: Given TIVA
Resection: Undergo surgical resection
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
3
|
|
Overall Study
Treatment
|
1
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
| Measure |
Arm I (Surgical Resection With TIVA)
Patients undergo surgical resection with TIVA.
Anesthesia Procedure: Given TIVA
Resection: Undergo surgical resection
|
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
|
|---|---|---|
|
Overall Study
Study terminated early due to principal investigator departing sponsoring organization
|
5
|
2
|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
Impact of Total Intravenous Anesthesia Following Cancer Surgery, TIVACS Study
Baseline characteristics by cohort
| Measure |
Arm I (Surgical Resection With TIVA)
n=5 Participants
Patients undergo surgical resection with TIVA.
Anesthesia Procedure: Given TIVA
Resection: Undergo surgical resection
|
Arm II (Surgical Resection With Inhaled Volatile Anesthetics)
n=3 Participants
Patients undergo surgical resection with inhaled volatile anesthetics.
General Anesthesia Procedure: Given inhaled volatile anesthetics
Resection: Undergo surgical resection
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=39 Participants
|
3 participants
n=41 Participants
|
8 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: 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.
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.
Outcome measures
Outcome data not reported
Adverse Events
Arm I (Surgical Resection With TIVA)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm II (Surgical Resection With Inhaled Volatile Anesthetics)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm I (Surgical Resection With TIVA)
n=5 participants at risk
Patients undergo surgical resection with TIVA.
Anesthesia Procedure: Given TIVA
Resection: Undergo surgical resection
|
Arm II (Surgical Resection With Inhaled Volatile Anesthetics)
n=3 participants at risk
Patients undergo surgical resection with inhaled volatile anesthetics.
General Anesthesia Procedure: Given inhaled volatile anesthetics
Resection: Undergo surgical resection
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
1/5 • Number of events 1 • From baseline until the study was terminated, an average of 1.5 months for each participant
|
33.3%
1/3 • Number of events 1 • From baseline until the study was terminated, an average of 1.5 months for each participant
|
|
Blood and lymphatic system disorders
Anemia
|
60.0%
3/5 • Number of events 3 • From baseline until the study was terminated, an average of 1.5 months for each participant
|
66.7%
2/3 • Number of events 2 • From baseline until the study was terminated, an average of 1.5 months for each participant
|
|
Investigations
Aspartate aminotransferase increased
|
40.0%
2/5 • Number of events 2 • From baseline until the study was terminated, an average of 1.5 months for each participant
|
33.3%
1/3 • Number of events 1 • From baseline until the study was terminated, an average of 1.5 months for each participant
|
|
Nervous system disorders
Dizziness
|
20.0%
1/5 • Number of events 1 • From baseline until the study was terminated, an average of 1.5 months for each participant
|
0.00%
0/3 • From baseline until the study was terminated, an average of 1.5 months for each participant
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
1/5 • Number of events 1 • From baseline until the study was terminated, an average of 1.5 months for each participant
|
0.00%
0/3 • From baseline until the study was terminated, an average of 1.5 months for each participant
|
|
Investigations
Alkaline phosphatase increased
|
20.0%
1/5 • Number of events 2 • From baseline until the study was terminated, an average of 1.5 months for each participant
|
0.00%
0/3 • From baseline until the study was terminated, an average of 1.5 months for each participant
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
20.0%
1/5 • Number of events 1 • From baseline until the study was terminated, an average of 1.5 months for each participant
|
0.00%
0/3 • From baseline until the study was terminated, an average of 1.5 months for each participant
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
20.0%
1/5 • Number of events 1 • From baseline until the study was terminated, an average of 1.5 months for each participant
|
0.00%
0/3 • From baseline until the study was terminated, an average of 1.5 months for each participant
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
60.0%
3/5 • Number of events 3 • From baseline until the study was terminated, an average of 1.5 months for each participant
|
66.7%
2/3 • Number of events 2 • From baseline until the study was terminated, an average of 1.5 months for each participant
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
40.0%
2/5 • Number of events 2 • From baseline until the study was terminated, an average of 1.5 months for each participant
|
33.3%
1/3 • Number of events 1 • From baseline until the study was terminated, an average of 1.5 months for each participant
|
|
Gastrointestinal disorders
Obstruction gastric
|
20.0%
1/5 • Number of events 1 • From baseline until the study was terminated, an average of 1.5 months for each participant
|
0.00%
0/3 • From baseline until the study was terminated, an average of 1.5 months for each participant
|
|
Gastrointestinal disorders
Pancreatitis
|
20.0%
1/5 • Number of events 1 • From baseline until the study was terminated, an average of 1.5 months for each participant
|
0.00%
0/3 • From baseline until the study was terminated, an average of 1.5 months for each participant
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
20.0%
1/5 • Number of events 1 • From baseline until the study was terminated, an average of 1.5 months for each participant
|
0.00%
0/3 • From baseline until the study was terminated, an average of 1.5 months for each participant
|
|
Investigations
Platelet count decreased
|
20.0%
1/5 • Number of events 2 • From baseline until the study was terminated, an average of 1.5 months for each participant
|
0.00%
0/3 • From baseline until the study was terminated, an average of 1.5 months for each participant
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/5 • From baseline until the study was terminated, an average of 1.5 months for each participant
|
33.3%
1/3 • Number of events 1 • From baseline until the study was terminated, an average of 1.5 months for each participant
|
|
General disorders
Gait disturbance
|
0.00%
0/5 • From baseline until the study was terminated, an average of 1.5 months for each participant
|
33.3%
1/3 • Number of events 1 • From baseline until the study was terminated, an average of 1.5 months for each participant
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/5 • From baseline until the study was terminated, an average of 1.5 months for each participant
|
33.3%
1/3 • Number of events 1 • From baseline until the study was terminated, an average of 1.5 months for each participant
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
0.00%
0/5 • From baseline until the study was terminated, an average of 1.5 months for each participant
|
33.3%
1/3 • Number of events 1 • From baseline until the study was terminated, an average of 1.5 months for each participant
|
|
Vascular disorders
Hypertension
|
0.00%
0/5 • From baseline until the study was terminated, an average of 1.5 months for each participant
|
33.3%
1/3 • Number of events 1 • From baseline until the study was terminated, an average of 1.5 months for each participant
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/5 • From baseline until the study was terminated, an average of 1.5 months for each participant
|
33.3%
1/3 • Number of events 1 • From baseline until the study was terminated, an average of 1.5 months for each participant
|
|
Investigations
Lipase increased
|
0.00%
0/5 • From baseline until the study was terminated, an average of 1.5 months for each participant
|
33.3%
1/3 • Number of events 1 • From baseline until the study was terminated, an average of 1.5 months for each participant
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/5 • From baseline until the study was terminated, an average of 1.5 months for each participant
|
33.3%
1/3 • Number of events 1 • From baseline until the study was terminated, an average of 1.5 months for each participant
|
Additional Information
Dr. Aslam Ejaz
The Ohio State University Comprehensive Cancer Center
Phone: 614-293-7171
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place