Trial Outcomes & Findings for Role of Propofol Postconditioning on Oxidative Stress and Cognitive Function (NCT NCT02691416)
NCT ID: NCT02691416
Last Updated: 2017-07-11
Results Overview
Evidences of clinically definite oxidative stress :Superoxide dismutase activity, Hydroxyl radical
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
60 participants
Primary outcome timeframe
before induction,after clamping removal ,operation ending ,1,3,7days post surgery
Results posted on
2017-07-11
Participant Flow
From July 2014 to January 2016, patients who were undergoing intracranial aneurysm surgery at hospital and consistent with the criterion of American Society of Anesthesiologists (ASA)Ⅰ-Ⅱ,but without severe hepatic and renal dysfunction, coagulation disorder were recruited.
Participant milestones
| Measure |
Propofol Postconditioning
Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately.
|
Sevoflurane
0.5%-2% sevoflurane
sevoflurane: 0.5%-2% sevoflurane with BIS 40-60
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Role of Propofol Postconditioning on Oxidative Stress and Cognitive Function
Baseline characteristics by cohort
| Measure |
Propofol Postconditioning
n=30 Participants
1.2ug/ml propofol Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately.
|
Sevoflurane
n=30 Participants
0.5%-2% sevoflurane
sevoflurane: 0.5%-2% sevoflurane with BIS 40-60
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: before induction,after clamping removal ,operation ending ,1,3,7days post surgeryEvidences of clinically definite oxidative stress :Superoxide dismutase activity, Hydroxyl radical
Outcome measures
| Measure |
Propofol Postconditioning
n=30 Participants
1.2ug/ml propofol
propofol: Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately.
|
Sevoflurane
n=30 Participants
0.5%-2% sevoflurane
sevoflurane: 0.5%-2% sevoflurane with BIS 40-60
|
|---|---|---|
|
Evidences of Clinically Definite Oxidative Stress Confirmed by ELISA Kit
Superoxide dismutase activity of before induction
|
72.87 U/ml
Standard Deviation 23.15
|
74.02 U/ml
Standard Deviation 21.27
|
|
Evidences of Clinically Definite Oxidative Stress Confirmed by ELISA Kit
Superoxide dismutase activity of clamping removal
|
67.10 U/ml
Standard Deviation 16.52
|
65.91 U/ml
Standard Deviation 16.07
|
|
Evidences of Clinically Definite Oxidative Stress Confirmed by ELISA Kit
Superoxide dismutase activity of operation ending
|
66.74 U/ml
Standard Deviation 16.50
|
51.58 U/ml
Standard Deviation 14.92
|
|
Evidences of Clinically Definite Oxidative Stress Confirmed by ELISA Kit
Superoxide dismutase activity of 1days postsurgery
|
66.80 U/ml
Standard Deviation 16.56
|
52.82 U/ml
Standard Deviation 14.93
|
|
Evidences of Clinically Definite Oxidative Stress Confirmed by ELISA Kit
Superoxide dismutase activity of 3days postsurgery
|
69.27 U/ml
Standard Deviation 16.66
|
57.35 U/ml
Standard Deviation 17.36
|
|
Evidences of Clinically Definite Oxidative Stress Confirmed by ELISA Kit
Superoxide dismutase activity of 7days postsurgery
|
69.02 U/ml
Standard Deviation 16.95
|
59.33 U/ml
Standard Deviation 17.30
|
|
Evidences of Clinically Definite Oxidative Stress Confirmed by ELISA Kit
Hydroxyl radical of before induction
|
5.30 U/ml
Standard Deviation 6.46
|
6.60 U/ml
Standard Deviation 6.49
|
|
Evidences of Clinically Definite Oxidative Stress Confirmed by ELISA Kit
Hydroxyl radical of clamping removal
|
15.80 U/ml
Standard Deviation 4.42
|
16.22 U/ml
Standard Deviation 5.23
|
|
Evidences of Clinically Definite Oxidative Stress Confirmed by ELISA Kit
Hydroxyl radical of operation ending
|
12.54 U/ml
Standard Deviation 4.32
|
15.29 U/ml
Standard Deviation 5.30
|
|
Evidences of Clinically Definite Oxidative Stress Confirmed by ELISA Kit
Hydroxyl radical of 1days post surgery
|
10.32 U/ml
Standard Deviation 4.61
|
13.65 U/ml
Standard Deviation 5.37
|
|
Evidences of Clinically Definite Oxidative Stress Confirmed by ELISA Kit
Hydroxyl radical of 3days post surgery
|
8.05 U/ml
Standard Deviation 4.80
|
12.46 U/ml
Standard Deviation 5.33
|
|
Evidences of Clinically Definite Oxidative Stress Confirmed by ELISA Kit
Hydroxyl radical of 7days post surgery
|
6.33 U/ml
Standard Deviation 5.57
|
10.32 U/ml
Standard Deviation 5.16
|
PRIMARY outcome
Timeframe: before induction, after clamping removal,operation ending,1,3,7days post surgeryEvidences of clinically definite oxidative stress:8-isoprostane,as a reliable biomarkers of lipid peroxidation
Outcome measures
| Measure |
Propofol Postconditioning
n=30 Participants
1.2ug/ml propofol
propofol: Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately.
|
Sevoflurane
n=30 Participants
0.5%-2% sevoflurane
sevoflurane: 0.5%-2% sevoflurane with BIS 40-60
|
|---|---|---|
|
Evidences of Clinically Definite Oxidative Stress Confirmed by ELISA
8-isoprostane of before induction
|
1.15 pg/ml
Standard Deviation 0.14
|
1.18 pg/ml
Standard Deviation 0.14
|
|
Evidences of Clinically Definite Oxidative Stress Confirmed by ELISA
8-isoprostane of clamping removal
|
1.19 pg/ml
Standard Deviation 0.15
|
1.22 pg/ml
Standard Deviation 0.14
|
|
Evidences of Clinically Definite Oxidative Stress Confirmed by ELISA
8-isoprostane of operation ending
|
1.54 pg/ml
Standard Deviation 0.16
|
1.70 pg/ml
Standard Deviation 0.18
|
|
Evidences of Clinically Definite Oxidative Stress Confirmed by ELISA
8-isoprostane of 1days post surgery
|
1.51 pg/ml
Standard Deviation 0.16
|
1.64 pg/ml
Standard Deviation 0.21
|
|
Evidences of Clinically Definite Oxidative Stress Confirmed by ELISA
8-isoprostane of 3days post surgery
|
1.48 pg/ml
Standard Deviation 0.17
|
1.60 pg/ml
Standard Deviation 0.18
|
|
Evidences of Clinically Definite Oxidative Stress Confirmed by ELISA
8-isoprostane of 7days post surgery
|
1.38 pg/ml
Standard Deviation 0.18
|
1.49 pg/ml
Standard Deviation 0.19
|
PRIMARY outcome
Timeframe: before induction,clamping removal ,operation ending,1,3,7days post surgeryEvidences of clinically definite oxidative stress:micronuclei confirmed by Cytokinesis-block Micronucleus Test
Outcome measures
| Measure |
Propofol Postconditioning
n=30 Participants
1.2ug/ml propofol
propofol: Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately.
|
Sevoflurane
n=30 Participants
0.5%-2% sevoflurane
sevoflurane: 0.5%-2% sevoflurane with BIS 40-60
|
|---|---|---|
|
Evidences of Clinically Definite Oxidative Stress:Micronuclei
micronuclei of before induction
|
185.83 number of micronuclei/1000 BN cells
Standard Deviation 21.69
|
186.40 number of micronuclei/1000 BN cells
Standard Deviation 19.87
|
|
Evidences of Clinically Definite Oxidative Stress:Micronuclei
micronuclei of clamping removal
|
194.57 number of micronuclei/1000 BN cells
Standard Deviation 25.27
|
195.73 number of micronuclei/1000 BN cells
Standard Deviation 24.21
|
|
Evidences of Clinically Definite Oxidative Stress:Micronuclei
micronuclei of operation ending
|
230.77 number of micronuclei/1000 BN cells
Standard Deviation 25.00
|
375.87 number of micronuclei/1000 BN cells
Standard Deviation 30.90
|
|
Evidences of Clinically Definite Oxidative Stress:Micronuclei
micronuclei of 1days post surgery
|
278.73 number of micronuclei/1000 BN cells
Standard Deviation 30.86
|
402.27 number of micronuclei/1000 BN cells
Standard Deviation 27.60
|
|
Evidences of Clinically Definite Oxidative Stress:Micronuclei
micronuclei of 3days post surgery
|
248.43 number of micronuclei/1000 BN cells
Standard Deviation 30.88
|
338.00 number of micronuclei/1000 BN cells
Standard Deviation 30.85
|
|
Evidences of Clinically Definite Oxidative Stress:Micronuclei
micronuclei of 7days post surgery
|
201.33 number of micronuclei/1000 BN cells
Standard Deviation 28.98
|
243.63 number of micronuclei/1000 BN cells
Standard Deviation 29.59
|
PRIMARY outcome
Timeframe: before induction,after clamping removal ,operation ending ,1,3,7days post surgeryEvidences of clinically definite oxidative stress :α- tocopherol,γ- tocopherol which was used to assess the antioxidant defense.
Outcome measures
| Measure |
Propofol Postconditioning
n=30 Participants
1.2ug/ml propofol
propofol: Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately.
|
Sevoflurane
n=30 Participants
0.5%-2% sevoflurane
sevoflurane: 0.5%-2% sevoflurane with BIS 40-60
|
|---|---|---|
|
Evidences of Clinically Definite Oxidative Stress Confirmed by High Performance Liquid Chromatography
α- tocopherol of before induction
|
12.67 ug/ml
Standard Deviation 1.96
|
12.22 ug/ml
Standard Deviation 1.83
|
|
Evidences of Clinically Definite Oxidative Stress Confirmed by High Performance Liquid Chromatography
α- tocopherol of clamping removal
|
6.13 ug/ml
Standard Deviation 1.81
|
6.12 ug/ml
Standard Deviation 1.68
|
|
Evidences of Clinically Definite Oxidative Stress Confirmed by High Performance Liquid Chromatography
α- tocopherol of opertaion ending
|
6.71 ug/ml
Standard Deviation 1.79
|
5.91 ug/ml
Standard Deviation 1.68
|
|
Evidences of Clinically Definite Oxidative Stress Confirmed by High Performance Liquid Chromatography
α- tocopherol of 1days post surgery
|
8.97 ug/ml
Standard Deviation 1.87
|
8.23 ug/ml
Standard Deviation 1.51
|
|
Evidences of Clinically Definite Oxidative Stress Confirmed by High Performance Liquid Chromatography
α- tocopherol of 3days post surgery
|
10.02 ug/ml
Standard Deviation 2.06
|
9.31 ug/ml
Standard Deviation 1.56
|
|
Evidences of Clinically Definite Oxidative Stress Confirmed by High Performance Liquid Chromatography
α- tocopherol of 7days post surgery
|
11.54 ug/ml
Standard Deviation 1.84
|
10.98 ug/ml
Standard Deviation 1.80
|
|
Evidences of Clinically Definite Oxidative Stress Confirmed by High Performance Liquid Chromatography
γ- tocopherol of before induction
|
0.52 ug/ml
Standard Deviation 0.08
|
0.53 ug/ml
Standard Deviation 0.08
|
|
Evidences of Clinically Definite Oxidative Stress Confirmed by High Performance Liquid Chromatography
γ- tocopherol of clamping removal
|
0.59 ug/ml
Standard Deviation 0.09
|
0.57 ug/ml
Standard Deviation 0.09
|
|
Evidences of Clinically Definite Oxidative Stress Confirmed by High Performance Liquid Chromatography
γ- tocopherol of opertaion ending
|
0.84 ug/ml
Standard Deviation 0.10
|
0.75 ug/ml
Standard Deviation 0.10
|
|
Evidences of Clinically Definite Oxidative Stress Confirmed by High Performance Liquid Chromatography
γ- tocopherol of 1days post surgery
|
0.76 ug/ml
Standard Deviation 0.11
|
0.69 ug/ml
Standard Deviation 0.10
|
|
Evidences of Clinically Definite Oxidative Stress Confirmed by High Performance Liquid Chromatography
γ- tocopherol of 3days post surgery
|
0.70 ug/ml
Standard Deviation 0.13
|
0.62 ug/ml
Standard Deviation 0.09
|
|
Evidences of Clinically Definite Oxidative Stress Confirmed by High Performance Liquid Chromatography
γ- tocopherol of 7days post surgery
|
0.68 ug/ml
Standard Deviation 0.13
|
0.60 ug/ml
Standard Deviation 0.11
|
PRIMARY outcome
Timeframe: before induction,clamping removal ,operation ending,1,3,7days post surgeryEvidences of clinically definite oxidative stress:nuclear buds Confirmed by Cytokinesis-block Micronucleus Test
Outcome measures
| Measure |
Propofol Postconditioning
n=30 Participants
1.2ug/ml propofol
propofol: Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately.
|
Sevoflurane
n=30 Participants
0.5%-2% sevoflurane
sevoflurane: 0.5%-2% sevoflurane with BIS 40-60
|
|---|---|---|
|
Evidences of Clinically Definite Oxidative Stress: Nuclear Buds
nuclear buds of before induction
|
50.40 number of nuclear buds/1000 BN cells
Standard Deviation 8.84
|
53.93 number of nuclear buds/1000 BN cells
Standard Deviation 9.11
|
|
Evidences of Clinically Definite Oxidative Stress: Nuclear Buds
nuclear buds of operation ending
|
61.10 number of nuclear buds/1000 BN cells
Standard Deviation 9.16
|
62.87 number of nuclear buds/1000 BN cells
Standard Deviation 10.47
|
|
Evidences of Clinically Definite Oxidative Stress: Nuclear Buds
nuclear buds of 1days post surgery
|
62.73 number of nuclear buds/1000 BN cells
Standard Deviation 10.38
|
65.07 number of nuclear buds/1000 BN cells
Standard Deviation 11.27
|
|
Evidences of Clinically Definite Oxidative Stress: Nuclear Buds
nuclear buds of 3days post surgery
|
58.00 number of nuclear buds/1000 BN cells
Standard Deviation 8.31
|
61.70 number of nuclear buds/1000 BN cells
Standard Deviation 10.03
|
|
Evidences of Clinically Definite Oxidative Stress: Nuclear Buds
nuclear buds of clamp ing removal
|
54.33 number of nuclear buds/1000 BN cells
Standard Deviation 8.56
|
57.43 number of nuclear buds/1000 BN cells
Standard Deviation 8.44
|
|
Evidences of Clinically Definite Oxidative Stress: Nuclear Buds
nuclear buds of 7days post surgery
|
54.87 number of nuclear buds/1000 BN cells
Standard Deviation 9.56
|
55.67 number of nuclear buds/1000 BN cells
Standard Deviation 11.49
|
PRIMARY outcome
Timeframe: before induction,clamping removal ,operation ending,1,3,7days post surgeryEvidences of clinically definite oxidative stress: nucleoplasmic bridges confirmed by Cytokinesis-block Micronucleus Test
Outcome measures
| Measure |
Propofol Postconditioning
n=30 Participants
1.2ug/ml propofol
propofol: Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately.
|
Sevoflurane
n=30 Participants
0.5%-2% sevoflurane
sevoflurane: 0.5%-2% sevoflurane with BIS 40-60
|
|---|---|---|
|
Evidences of Clinically Definite Oxidative Stress: Nucleoplasmic Bridges
nucleoplasmic bridges of before induction
|
66.50 number of nucleoplasmic bridges/1000 BN
Standard Deviation 9.92
|
68.73 number of nucleoplasmic bridges/1000 BN
Standard Deviation 8.22
|
|
Evidences of Clinically Definite Oxidative Stress: Nucleoplasmic Bridges
nucleoplasmic bridges of clamp ing removal
|
78.77 number of nucleoplasmic bridges/1000 BN
Standard Deviation 13.66
|
80.80 number of nucleoplasmic bridges/1000 BN
Standard Deviation 12.34
|
|
Evidences of Clinically Definite Oxidative Stress: Nucleoplasmic Bridges
nucleoplasmic bridges of operation ending
|
88.40 number of nucleoplasmic bridges/1000 BN
Standard Deviation 14.08
|
96.23 number of nucleoplasmic bridges/1000 BN
Standard Deviation 12.70
|
|
Evidences of Clinically Definite Oxidative Stress: Nucleoplasmic Bridges
nucleoplasmic bridges of 1days post surgery
|
96.83 number of nucleoplasmic bridges/1000 BN
Standard Deviation 14.74
|
111.93 number of nucleoplasmic bridges/1000 BN
Standard Deviation 11.77
|
|
Evidences of Clinically Definite Oxidative Stress: Nucleoplasmic Bridges
nucleoplasmic bridges of 3days post surgery
|
86.87 number of nucleoplasmic bridges/1000 BN
Standard Deviation 11.29
|
96.37 number of nucleoplasmic bridges/1000 BN
Standard Deviation 12.70
|
|
Evidences of Clinically Definite Oxidative Stress: Nucleoplasmic Bridges
nucleoplasmic bridges of 7days post surgery
|
79.20 number of nucleoplasmic bridges/1000 BN
Standard Deviation 11.17
|
87.83 number of nucleoplasmic bridges/1000 BN
Standard Deviation 12.85
|
SECONDARY outcome
Timeframe: before induction,1,3,7days post surgeryA questionnaires is used to assess the cognitive function of patients in clinical,the total range was 0-30,and 27-30 were considered as normal value,\<27 were considered as recognitive dysfunction.
Outcome measures
| Measure |
Propofol Postconditioning
n=30 Participants
1.2ug/ml propofol
propofol: Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately.
|
Sevoflurane
n=30 Participants
0.5%-2% sevoflurane
sevoflurane: 0.5%-2% sevoflurane with BIS 40-60
|
|---|---|---|
|
Mini Mental State Examination (MMSE)
before induction of MMSE
|
27.63 units on a scale
Standard Deviation 1.43
|
27.23 units on a scale
Standard Deviation 1.63
|
|
Mini Mental State Examination (MMSE)
1days post surgery of MMSE
|
23.40 units on a scale
Standard Deviation 1.87
|
17.73 units on a scale
Standard Deviation 2.02
|
|
Mini Mental State Examination (MMSE)
3 days post surgery of MMSE
|
24.43 units on a scale
Standard Deviation 2.18
|
20.33 units on a scale
Standard Deviation 1.94
|
|
Mini Mental State Examination (MMSE)
7 days post surgery of MMSE
|
27.00 units on a scale
Standard Deviation 2.00
|
24.30 units on a scale
Standard Deviation 1.97
|
SECONDARY outcome
Timeframe: before induction,1,3,7days post surgeryA questionnaires is used to assess the cognitive function of patients in clinical,the total range was 0-30,and 27-30 were considered as normal value,\<27 were considered as recognitive dysfunction.
Outcome measures
| Measure |
Propofol Postconditioning
n=30 Participants
1.2ug/ml propofol
propofol: Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately.
|
Sevoflurane
n=30 Participants
0.5%-2% sevoflurane
sevoflurane: 0.5%-2% sevoflurane with BIS 40-60
|
|---|---|---|
|
Montreal Cognitive Assessment (MoCA)
before induction of MoCA
|
20.43 units on a scale
Standard Deviation 2.39
|
19.87 units on a scale
Standard Deviation 2.60
|
|
Montreal Cognitive Assessment (MoCA)
1days post surgery
|
21.53 units on a scale
Standard Deviation 2.58
|
19.20 units on a scale
Standard Deviation 2.31
|
|
Montreal Cognitive Assessment (MoCA)
3days post surgery
|
22.53 units on a scale
Standard Deviation 2.68
|
20.80 units on a scale
Standard Deviation 2.73
|
|
Montreal Cognitive Assessment (MoCA)
7days post surgery
|
26.20 units on a scale
Standard Deviation 2.27
|
23.10 units on a scale
Standard Deviation 2.73
|
Adverse Events
Propofol Postconditioning
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sevoflurane
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
Dr.Haiyun Wang
The Third Central Clinical College of Tianjin Medical University, Tianjin the Third Central Hospital
Phone: 13752211206
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place