A Phase 4 interventional study of propofol postconditioning and sevoflurane in Cerebral Arterial Aneurysm, sponsored by The Third Central Clinical College of Tianjin Medical University. Completed. Per ClinicalTrials.gov, last updated 2017-07-11.
Sponsored by The Third Central Clinical College of Tianjin Medical University · Phase 4, Interventional, and Prevention
The purpose of this study was to evaluate differences between propofol postconditioning and sevoflurane anesthesia in the intracranial aneurysm surgery about antioxidant effect.
intracranial aneurysm surgery may lead to regional ischemic reperfusion injury. Propofol, as an antioxidative phenol, has been demonstrated that mitigate the brain I/R in rats.
As for sevoflurane, some investigation indicated that sevoflurane is able to reduce oxidative stress in cell(except neuronal cell lines ) and rodent models, but the antioxidant effect did not found in human minor incision surgeries, furthermore, oxidative stress was raised in the major surgeries including orthopedic surgeries, hysterectomy, cholecystectomy, and thoracotomy
960 studies on the registry are indexed under Aneurysm; 175 are open to participants now.
This study's enrollment of 60 is below the median of 72 across 462 interventional studies indexed under Aneurysm.
Browse Aneurysm studies →The Third Central Clinical College of Tianjin Medical University is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1.2mg/L propofol
Drug: propofol postconditioning · Drug: sevoflurane
0.5%-2% sevoflurane
Drug: sevoflurane
administrated Target Controlled Infusion(TCI) of propofol (Cp 1.2ug/ml) and decreased sevoflurane with a Bispectral index (BIS) value of 40-60 to maintain anesthesia after clamp removal
0.5%-2% sevoflurane with BIS 40-60
Evidences of Clinically Definite Oxidative Stress Confirmed by ELISA Kit
Evidences of clinically definite oxidative stress :Superoxide dismutase activity, Hydroxyl radical
Time frame: before induction,after clamping removal ,operation ending ,1,3,7days post surgery
Evidences of Clinically Definite Oxidative Stress Confirmed by ELISA
Evidences of clinically definite oxidative stress:8-isoprostane,as a reliable biomarkers of lipid peroxidation
Time frame: before induction, after clamping removal,operation ending,1,3,7days post surgery
Evidences of Clinically Definite Oxidative Stress:Micronuclei
Evidences of clinically definite oxidative stress:micronuclei confirmed by Cytokinesis-block Micronucleus Test
Time frame: before induction,clamping removal ,operation ending,1,3,7days post surgery
Evidences of Clinically Definite Oxidative Stress Confirmed by High Performance Liquid Chromatography
Evidences of clinically definite oxidative stress :α- tocopherol,γ- tocopherol which was used to assess the antioxidant defense.
Time frame: before induction,after clamping removal ,operation ending ,1,3,7days post surgery
Evidences of Clinically Definite Oxidative Stress: Nuclear Buds
Evidences of clinically definite oxidative stress:nuclear buds Confirmed by Cytokinesis-block Micronucleus Test
Time frame: before induction,clamping removal ,operation ending,1,3,7days post surgery
Evidences of Clinically Definite Oxidative Stress: Nucleoplasmic Bridges
Evidences of clinically definite oxidative stress: nucleoplasmic bridges confirmed by Cytokinesis-block Micronucleus Test
Time frame: before induction,clamping removal ,operation ending,1,3,7days post surgery
Mini Mental State Examination (MMSE)
A 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.
Time frame: before induction,1,3,7days post surgery
Montreal Cognitive Assessment (MoCA)
A 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.
Time frame: before induction,1,3,7days post surgery
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.
| Milestone | Propofol Postconditioning | Sevoflurane |
|---|---|---|
| Started | 30 | 30 |
| Completed | 30 | 30 |
| Not completed | 0 | 0 |
Evidences of clinically definite oxidative stress :Superoxide dismutase activity, Hydroxyl radical
| U/ml | Propofol Postconditioning | Sevoflurane |
|---|---|---|
| Superoxide dismutase activity of before induction | 72.87 ± 23.15 | 74.02 ± 21.27 |
| Superoxide dismutase activity of clamping removal | 67.10 ± 16.52 | 65.91 ± 16.07 |
| Superoxide dismutase activity of operation ending | 66.74 ± 16.50 | 51.58 ± 14.92 |
| Superoxide dismutase activity of 1days postsurgery | 66.80 ± 16.56 | 52.82 ± 14.93 |
| Superoxide dismutase activity of 3days postsurgery | 69.27 ± 16.66 | 57.35 ± 17.36 |
| Superoxide dismutase activity of 7days postsurgery | 69.02 ± 16.95 | 59.33 ± 17.30 |
| Hydroxyl radical of before induction | 5.30 ± 6.46 | 6.60 ± 6.49 |
| Hydroxyl radical of clamping removal | 15.80 ± 4.42 | 16.22 ± 5.23 |
| Hydroxyl radical of operation ending | 12.54 ± 4.32 | 15.29 ± 5.30 |
| Hydroxyl radical of 1days post surgery | 10.32 ± 4.61 | 13.65 ± 5.37 |
| Hydroxyl radical of 3days post surgery | 8.05 ± 4.80 | 12.46 ± 5.33 |
| Hydroxyl radical of 7days post surgery | 6.33 ± 5.57 | 10.32 ± 5.16 |
Evidences of clinically definite oxidative stress:8-isoprostane,as a reliable biomarkers of lipid peroxidation
| pg/ml | Propofol Postconditioning | Sevoflurane |
|---|---|---|
| 8-isoprostane of before induction | 1.15 ± 0.14 | 1.18 ± 0.14 |
| 8-isoprostane of clamping removal | 1.19 ± 0.15 | 1.22 ± 0.14 |
| 8-isoprostane of operation ending | 1.54 ± 0.16 | 1.70 ± 0.18 |
| 8-isoprostane of 1days post surgery | 1.51 ± 0.16 | 1.64 ± 0.21 |
| 8-isoprostane of 3days post surgery | 1.48 ± 0.17 | 1.60 ± 0.18 |
| 8-isoprostane of 7days post surgery | 1.38 ± 0.18 | 1.49 ± 0.19 |
Evidences of clinically definite oxidative stress:micronuclei confirmed by Cytokinesis-block Micronucleus Test
| number of micronuclei/1000 BN cells | Propofol Postconditioning | Sevoflurane |
|---|---|---|
| micronuclei of before induction | 185.83 ± 21.69 | 186.40 ± 19.87 |
| micronuclei of clamping removal | 194.57 ± 25.27 | 195.73 ± 24.21 |
| micronuclei of operation ending | 230.77 ± 25.00 | 375.87 ± 30.90 |
| micronuclei of 1days post surgery | 278.73 ± 30.86 | 402.27 ± 27.60 |
| micronuclei of 3days post surgery | 248.43 ± 30.88 | 338.00 ± 30.85 |
| micronuclei of 7days post surgery | 201.33 ± 28.98 | 243.63 ± 29.59 |
Evidences of clinically definite oxidative stress :α- tocopherol,γ- tocopherol which was used to assess the antioxidant defense.
| ug/ml | Propofol Postconditioning | Sevoflurane |
|---|---|---|
| α- tocopherol of before induction | 12.67 ± 1.96 | 12.22 ± 1.83 |
| α- tocopherol of clamping removal | 6.13 ± 1.81 | 6.12 ± 1.68 |
| α- tocopherol of opertaion ending | 6.71 ± 1.79 | 5.91 ± 1.68 |
| α- tocopherol of 1days post surgery | 8.97 ± 1.87 | 8.23 ± 1.51 |
| α- tocopherol of 3days post surgery | 10.02 ± 2.06 | 9.31 ± 1.56 |
| α- tocopherol of 7days post surgery | 11.54 ± 1.84 | 10.98 ± 1.80 |
| γ- tocopherol of before induction | 0.52 ± 0.08 | 0.53 ± 0.08 |
| γ- tocopherol of clamping removal | 0.59 ± 0.09 | 0.57 ± 0.09 |
| γ- tocopherol of opertaion ending | 0.84 ± 0.10 | 0.75 ± 0.10 |
| γ- tocopherol of 1days post surgery | 0.76 ± 0.11 | 0.69 ± 0.10 |
| γ- tocopherol of 3days post surgery | 0.70 ± 0.13 | 0.62 ± 0.09 |
| γ- tocopherol of 7days post surgery | 0.68 ± 0.13 | 0.60 ± 0.11 |
Evidences of clinically definite oxidative stress:nuclear buds Confirmed by Cytokinesis-block Micronucleus Test
| number of nuclear buds/1000 BN cells | Propofol Postconditioning | Sevoflurane |
|---|---|---|
| nuclear buds of before induction | 50.40 ± 8.84 | 53.93 ± 9.11 |
| nuclear buds of clamp ing removal | 54.33 ± 8.56 | 57.43 ± 8.44 |
| nuclear buds of operation ending | 61.10 ± 9.16 | 62.87 ± 10.47 |
| nuclear buds of 1days post surgery | 62.73 ± 10.38 | 65.07 ± 11.27 |
| nuclear buds of 3days post surgery | 58.00 ± 8.31 | 61.70 ± 10.03 |
| nuclear buds of 7days post surgery | 54.87 ± 9.56 | 55.67 ± 11.49 |
Evidences of clinically definite oxidative stress: nucleoplasmic bridges confirmed by Cytokinesis-block Micronucleus Test
| number of nucleoplasmic bridges/1000 BN | Propofol Postconditioning | Sevoflurane |
|---|---|---|
| nucleoplasmic bridges of before induction | 66.50 ± 9.92 | 68.73 ± 8.22 |
| nucleoplasmic bridges of clamp ing removal | 78.77 ± 13.66 | 80.80 ± 12.34 |
| nucleoplasmic bridges of operation ending | 88.40 ± 14.08 | 96.23 ± 12.70 |
| nucleoplasmic bridges of 1days post surgery | 96.83 ± 14.74 | 111.93 ± 11.77 |
| nucleoplasmic bridges of 3days post surgery | 86.87 ± 11.29 | 96.37 ± 12.70 |
| nucleoplasmic bridges of 7days post surgery | 79.20 ± 11.17 | 87.83 ± 12.85 |
A 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.
| units on a scale | Propofol Postconditioning | Sevoflurane |
|---|---|---|
| before induction of MMSE | 27.63 ± 1.43 | 27.23 ± 1.63 |
| 1days post surgery of MMSE | 23.40 ± 1.87 | 17.73 ± 2.02 |
| 3 days post surgery of MMSE | 24.43 ± 2.18 | 20.33 ± 1.94 |
| 7 days post surgery of MMSE | 27.00 ± 2.00 | 24.30 ± 1.97 |
A 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.
| units on a scale | Propofol Postconditioning | Sevoflurane |
|---|---|---|
| before induction of MoCA | 20.43 ± 2.39 | 19.87 ± 2.60 |
| 1days post surgery | 21.53 ± 2.58 | 19.20 ± 2.31 |
| 3days post surgery | 22.53 ± 2.68 | 20.80 ± 2.73 |
| 7days post surgery | 26.20 ± 2.27 | 23.10 ± 2.73 |
Collected over 7days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Propofol Postconditioning | — | 0/30 (0%) | 0/30 (0%) |
| Sevoflurane | — | 0/30 (0%) | 0/30 (0%) |
| Age, Categorical(Participants) | Propofol Postconditioning | Sevoflurane | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 30 | 30 | 60 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Propofol Postconditioning | Sevoflurane | Total |
|---|---|---|---|
| Female | 16 | 17 | 33 |
| Male | 14 | 13 | 27 |
| Region of Enrollment(participants) | Propofol Postconditioning | Sevoflurane | Total |
|---|---|---|---|
| China | 30 | 30 | 60 |
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The Third Central Clinical College of Tianjin Medical University