Trial Outcomes & Findings for Comparison of Total Oxidant and Total Antioxidant Capacities in Low-Flow and High-Flow General Anesthesia (NCT NCT05590312)
NCT ID: NCT05590312
Last Updated: 2025-01-17
Results Overview
Vitamin D, Albumin, CRP, TAS and TOS values will be checked before the operation in 72 patients who will receive general anesthesia in both groups. Albumin, CRP, TAS and TOS values will be checked again from the blood taken postoperatively in the patients who were taken to the ward after the operation and these values will be compared between two groups and with the previous level in the same group.
Recruitment status
COMPLETED
Target enrollment
72 participants
Primary outcome timeframe
3 times in 24 hours perioperatively. TAS/TOS levels will be determined before the operation, at the end of operation and at 6th hour after the end of operation.
Results posted on
2025-01-17
Participant Flow
Participant milestones
| Measure |
Low Flow Group - Group D
Vitamin D, Albumin, CRP, TAS and TOS values will be checked before and during the operation in 36 patients who will receive general anesthesia. Flow of 1 L/min will be given during the operation. The processed EEG values of all patients will be monitored and they will be ensured to be at the same anesthesia depth. Albumin, CRP, TAS and TOS values will be checked again from the blood taken postoperatively in the patients who were taken to the service after the operation and these values will be compared with the previous ones.
general anesthesia: All patients will undergo general anesthesia. Group D will receive fresh gas flow of 1 l/min and Group Y will receive fresh gas flow of 4 l/min.
|
High Flow Group - Group Y
Vitamin D, Albumin, CRP, TAS and TOS values will be checked before and during the operation in 36 patients who will receive general anesthesia. Flow of 4 L/min will be given during the operation. The processed EEG values of all patients will be monitored and they will be ensured to be at the same anesthesia depth. Albumin, CRP, TAS and TOS values will be checked again from the blood taken postoperatively in the patients who were taken to the service after the operation and these values will be compared with the previous ones.
general anesthesia: All patients will undergo general anesthesia. Group D will receive fresh gas flow of 1 l/min and Group Y will receive fresh gas flow of 4 l/min.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
36
|
|
Overall Study
COMPLETED
|
36
|
36
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Low Flow Group - Group D
n=36 Participants
Vitamin D, Albumin, CRP, TAS and TOS values will be checked before and during the operation in 36 patients who will receive general anesthesia. Flow of 1 L/min will be given during the operation. The processed EEG values of all patients will be monitored and they will be ensured to be at the same anesthesia depth. Albumin, CRP, TAS and TOS values will be checked again from the blood taken postoperatively in the patients who were taken to the service after the operation and these values will be compared with the previous ones.
general anesthesia: All patients will undergo general anesthesia. Group D will receive fresh gas flow of 1 l/min and Group Y will receive fresh gas flow of 4 l/min.
|
High Flow Group - Group Y
n=36 Participants
Vitamin D, Albumin, CRP, TAS and TOS values will be checked before and during the operation in 36 patients who will receive general anesthesia. Flow of 4 L/min will be given during the operation. The processed EEG values of all patients will be monitored and they will be ensured to be at the same anesthesia depth. Albumin, CRP, TAS and TOS values will be checked again from the blood taken postoperatively in the patients who were taken to the service after the operation and these values will be compared with the previous ones.
general anesthesia: All patients will undergo general anesthesia. Group D will receive fresh gas flow of 1 l/min and Group Y will receive fresh gas flow of 4 l/min.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=72 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
36 Participants
n=36 Participants
|
36 Participants
n=36 Participants
|
72 Participants
n=72 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=72 Participants
|
|
Age, Continuous
|
34 years
STANDARD_DEVIATION 11 • n=36 Participants
|
39 years
STANDARD_DEVIATION 12 • n=36 Participants
|
37 years
STANDARD_DEVIATION 11 • n=72 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=36 Participants
|
15 Participants
n=36 Participants
|
31 Participants
n=72 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=36 Participants
|
21 Participants
n=36 Participants
|
41 Participants
n=72 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Turkey
|
36 participants
n=36 Participants
|
36 participants
n=36 Participants
|
72 participants
n=72 Participants
|
|
Fresh gas flow
|
1 liter/minute
n=36 Participants
|
4 liter/minute
n=36 Participants
|
2.5 liter/minute
n=72 Participants
|
PRIMARY outcome
Timeframe: 3 times in 24 hours perioperatively. TAS/TOS levels will be determined before the operation, at the end of operation and at 6th hour after the end of operation.Vitamin D, Albumin, CRP, TAS and TOS values will be checked before the operation in 72 patients who will receive general anesthesia in both groups. Albumin, CRP, TAS and TOS values will be checked again from the blood taken postoperatively in the patients who were taken to the ward after the operation and these values will be compared between two groups and with the previous level in the same group.
Outcome measures
| Measure |
Low Flow Group - Group D
n=36 Participants
Vitamin D, Albumin, CRP, TAS and TOS values will be checked before and during the operation in 36 patients who will receive general anesthesia. Flow of 1 L/min will be given during the operation. The processed EEG values of all patients will be monitored and they will be ensured to be at the same anesthesia depth. Albumin, CRP, TAS and TOS values will be checked again from the blood taken postoperatively in the patients who were taken to the service after the operation and these values will be compared with the previous ones.
general anesthesia: All patients will undergo general anesthesia. Group D will receive fresh gas flow of 1 l/min and Group Y will receive fresh gas flow of 4 l/min.
|
High Flow Group - Group Y
n=36 Participants
Vitamin D, Albumin, CRP, TAS and TOS values will be checked before and during the operation in 36 patients who will receive general anesthesia. Flow of 4 L/min will be given during the operation. The processed EEG values of all patients will be monitored and they will be ensured to be at the same anesthesia depth. Albumin, CRP, TAS and TOS values will be checked again from the blood taken postoperatively in the patients who were taken to the service after the operation and these values will be compared with the previous ones.
general anesthesia: All patients will undergo general anesthesia. Group D will receive fresh gas flow of 1 l/min and Group Y will receive fresh gas flow of 4 l/min.
|
|---|---|---|
|
Comparison of Total Antioxidant Status (TAS) Levels Between the Two Groups
T0: Before the operation
|
1.76 mmol Eq / L
Standard Deviation 0.23
|
1.82 mmol Eq / L
Standard Deviation 0.3
|
|
Comparison of Total Antioxidant Status (TAS) Levels Between the Two Groups
T1: At the end of the operation
|
1.83 mmol Eq / L
Standard Deviation 0.24
|
1.92 mmol Eq / L
Standard Deviation 0.27
|
|
Comparison of Total Antioxidant Status (TAS) Levels Between the Two Groups
T2: At 6th hour after the end of the operation
|
1.85 mmol Eq / L
Standard Deviation 0.28
|
1.89 mmol Eq / L
Standard Deviation 0.29
|
PRIMARY outcome
Timeframe: 3 times in 24 hours perioperatively. TAS/TOS levels will be determined before the operation, at the end of operation and at 6th hour after the end of operation.Vitamin D, Albumin, CRP, TAS and TOS values will be checked before the operation in 72 patients who will receive general anesthesia in both groups. Albumin, CRP, TAS and TOS values will be checked again from the blood taken postoperatively in the patients who were taken to the ward after the operation and these values will be compared between two groups and with the previous level in the same group.
Outcome measures
| Measure |
Low Flow Group - Group D
n=36 Participants
Vitamin D, Albumin, CRP, TAS and TOS values will be checked before and during the operation in 36 patients who will receive general anesthesia. Flow of 1 L/min will be given during the operation. The processed EEG values of all patients will be monitored and they will be ensured to be at the same anesthesia depth. Albumin, CRP, TAS and TOS values will be checked again from the blood taken postoperatively in the patients who were taken to the service after the operation and these values will be compared with the previous ones.
general anesthesia: All patients will undergo general anesthesia. Group D will receive fresh gas flow of 1 l/min and Group Y will receive fresh gas flow of 4 l/min.
|
High Flow Group - Group Y
n=36 Participants
Vitamin D, Albumin, CRP, TAS and TOS values will be checked before and during the operation in 36 patients who will receive general anesthesia. Flow of 4 L/min will be given during the operation. The processed EEG values of all patients will be monitored and they will be ensured to be at the same anesthesia depth. Albumin, CRP, TAS and TOS values will be checked again from the blood taken postoperatively in the patients who were taken to the service after the operation and these values will be compared with the previous ones.
general anesthesia: All patients will undergo general anesthesia. Group D will receive fresh gas flow of 1 l/min and Group Y will receive fresh gas flow of 4 l/min.
|
|---|---|---|
|
Change From Baseline in Total Oxidant Status (TOS) Levels
T0: before the operation
|
19.82 µmol H2O2 q/L
Standard Deviation 11.82
|
21.48 µmol H2O2 q/L
Standard Deviation 11.01
|
|
Change From Baseline in Total Oxidant Status (TOS) Levels
T1: at the end of operation
|
19.66 µmol H2O2 q/L
Standard Deviation 11.75
|
17.20 µmol H2O2 q/L
Standard Deviation 8.72
|
|
Change From Baseline in Total Oxidant Status (TOS) Levels
T2: at 6th hour after the end of operation.
|
22.49 µmol H2O2 q/L
Standard Deviation 11.99
|
21.38 µmol H2O2 q/L
Standard Deviation 11.64
|
PRIMARY outcome
Timeframe: 3 times in 24 hours perioperatively. Albumin levels will be determined before the operation, at the end of operation and at 6th hour after the end of operation.Vitamin D, Albumin, CRP, TAS and TOS values will be checked before the operation in 72 patients who will receive general anesthesia in both groups. Albumin, CRP, TAS and TOS values will be checked again from the blood taken postoperatively in the patients who were taken to the ward after the operation and these values will be compared between two groups and with the previous level in the same group.
Outcome measures
| Measure |
Low Flow Group - Group D
n=36 Participants
Vitamin D, Albumin, CRP, TAS and TOS values will be checked before and during the operation in 36 patients who will receive general anesthesia. Flow of 1 L/min will be given during the operation. The processed EEG values of all patients will be monitored and they will be ensured to be at the same anesthesia depth. Albumin, CRP, TAS and TOS values will be checked again from the blood taken postoperatively in the patients who were taken to the service after the operation and these values will be compared with the previous ones.
general anesthesia: All patients will undergo general anesthesia. Group D will receive fresh gas flow of 1 l/min and Group Y will receive fresh gas flow of 4 l/min.
|
High Flow Group - Group Y
n=36 Participants
Vitamin D, Albumin, CRP, TAS and TOS values will be checked before and during the operation in 36 patients who will receive general anesthesia. Flow of 4 L/min will be given during the operation. The processed EEG values of all patients will be monitored and they will be ensured to be at the same anesthesia depth. Albumin, CRP, TAS and TOS values will be checked again from the blood taken postoperatively in the patients who were taken to the service after the operation and these values will be compared with the previous ones.
general anesthesia: All patients will undergo general anesthesia. Group D will receive fresh gas flow of 1 l/min and Group Y will receive fresh gas flow of 4 l/min.
|
|---|---|---|
|
Change From Baseline in Albumin Levels.
T0: before the operation
|
4.24 mg/dL
Standard Deviation 0.3
|
4.15 mg/dL
Standard Deviation 0.24
|
|
Change From Baseline in Albumin Levels.
T1: at the end of operation
|
4.05 mg/dL
Standard Deviation 0.38
|
4.02 mg/dL
Standard Deviation 0.39
|
|
Change From Baseline in Albumin Levels.
T2: at 6th hour after the end of operation.
|
3.96 mg/dL
Standard Deviation 0.36
|
3.97 mg/dL
Standard Deviation 0.40
|
PRIMARY outcome
Timeframe: 3 times in 24 hours perioperatively. Albumin levels will be determined before the operation, at the end of operation and at 6th hour after the end of operation.Vitamin D, Albumin, CRP, TAS and TOS values will be checked before the operation in 72 patients who will receive general anesthesia in both groups. Albumin, CRP, TAS and TOS values will be checked again from the blood taken postoperatively in the patients who were taken to the ward after the operation and these values will be compared between two groups and with the previous level in the same group.
Outcome measures
| Measure |
Low Flow Group - Group D
n=36 Participants
Vitamin D, Albumin, CRP, TAS and TOS values will be checked before and during the operation in 36 patients who will receive general anesthesia. Flow of 1 L/min will be given during the operation. The processed EEG values of all patients will be monitored and they will be ensured to be at the same anesthesia depth. Albumin, CRP, TAS and TOS values will be checked again from the blood taken postoperatively in the patients who were taken to the service after the operation and these values will be compared with the previous ones.
general anesthesia: All patients will undergo general anesthesia. Group D will receive fresh gas flow of 1 l/min and Group Y will receive fresh gas flow of 4 l/min.
|
High Flow Group - Group Y
n=36 Participants
Vitamin D, Albumin, CRP, TAS and TOS values will be checked before and during the operation in 36 patients who will receive general anesthesia. Flow of 4 L/min will be given during the operation. The processed EEG values of all patients will be monitored and they will be ensured to be at the same anesthesia depth. Albumin, CRP, TAS and TOS values will be checked again from the blood taken postoperatively in the patients who were taken to the service after the operation and these values will be compared with the previous ones.
general anesthesia: All patients will undergo general anesthesia. Group D will receive fresh gas flow of 1 l/min and Group Y will receive fresh gas flow of 4 l/min.
|
|---|---|---|
|
Change From Baseline in C Reactive Protein (CRP) Levels.
T2: at 6th hour after the end of operation.
|
1.41 mg/dL
Standard Deviation 2.58
|
1.37 mg/dL
Standard Deviation 2.31
|
|
Change From Baseline in C Reactive Protein (CRP) Levels.
T0: before the operation
|
0.30 mg/dL
Standard Deviation 0.54
|
0.53 mg/dL
Standard Deviation 1.61
|
|
Change From Baseline in C Reactive Protein (CRP) Levels.
T1: at the end of operation
|
0.31 mg/dL
Standard Deviation 0.56
|
0.52 mg/dL
Standard Deviation 1.36
|
PRIMARY outcome
Timeframe: 1 time before the operation.Vitamin D, Albumin, CRP, TAS and TOS values will be checked before the operation in 72 patients who will receive general anesthesia in both groups. Albumin, CRP, TAS and TOS values will be checked again from the blood taken postoperatively in the patients who were taken to the ward after the operation and these values will be compared between two groups and with the previous level in the same group.
Outcome measures
| Measure |
Low Flow Group - Group D
n=36 Participants
Vitamin D, Albumin, CRP, TAS and TOS values will be checked before and during the operation in 36 patients who will receive general anesthesia. Flow of 1 L/min will be given during the operation. The processed EEG values of all patients will be monitored and they will be ensured to be at the same anesthesia depth. Albumin, CRP, TAS and TOS values will be checked again from the blood taken postoperatively in the patients who were taken to the service after the operation and these values will be compared with the previous ones.
general anesthesia: All patients will undergo general anesthesia. Group D will receive fresh gas flow of 1 l/min and Group Y will receive fresh gas flow of 4 l/min.
|
High Flow Group - Group Y
n=36 Participants
Vitamin D, Albumin, CRP, TAS and TOS values will be checked before and during the operation in 36 patients who will receive general anesthesia. Flow of 4 L/min will be given during the operation. The processed EEG values of all patients will be monitored and they will be ensured to be at the same anesthesia depth. Albumin, CRP, TAS and TOS values will be checked again from the blood taken postoperatively in the patients who were taken to the service after the operation and these values will be compared with the previous ones.
general anesthesia: All patients will undergo general anesthesia. Group D will receive fresh gas flow of 1 l/min and Group Y will receive fresh gas flow of 4 l/min.
|
|---|---|---|
|
Comparison of Vitamin D Levels Between the Two Groups
|
7.5 mg/dL
Standard Deviation 10.9
|
14.8 mg/dL
Standard Deviation 13
|
Adverse Events
Low Flow Group - Group D
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High Flow Group - Group Y
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Assistant Professor Özlem Ersoy Karka
Düzce University Faculty of Medicine
Phone: +905337293978
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place