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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| propofol postconditioning | Experimental | 1.2mg/L propofol |
|
| sevoflurane | Experimental | 0.5%-2% sevoflurane |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| propofol postconditioning | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Evidences of Clinically Definite Oxidative Stress Confirmed by ELISA Kit | Evidences of clinically definite oxidative stress :Superoxide dismutase activity, Hydroxyl radical | 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 | 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 | 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. | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | before induction,1,3,7days post surgery |
| Montreal Cognitive Assessment (MoCA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Haiyun Wang | The Third Central Clinical College of Tianjin Medical University | Study Director |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Sevoflurane | 0.5%-2% sevoflurane sevoflurane: 0.5%-2% sevoflurane with BIS 40-60 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Propofol Postconditioning | 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. |
| BG001 | Sevoflurane |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Evidences of Clinically Definite Oxidative Stress Confirmed by ELISA Kit | Evidences of clinically definite oxidative stress :Superoxide dismutase activity, Hydroxyl radical | Posted | Mean | Standard Deviation | U/ml | before induction,after clamping removal ,operation ending ,1,3,7days post surgery |
|
7days
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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 | Propofol Postconditioning | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Haiyun Wang | The Third Central Clinical College of Tianjin Medical University, Tianjin the Third Central Hospital | 13752211206 | why819@126.com |
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| ID | Term |
|---|---|
| D000077149 | Sevoflurane |
| ID | Term |
|---|---|
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D006845 | Hydrocarbons, Fluorinated |
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| sevoflurane | Drug | 0.5%-2% sevoflurane with BIS 40-60 |
|
| before induction,clamping removal ,operation ending,1,3,7days post surgery |
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. |
| before induction,1,3,7days post surgery |
0.5%-2% sevoflurane sevoflurane: 0.5%-2% sevoflurane with BIS 40-60 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Evidences of Clinically Definite Oxidative Stress Confirmed by ELISA | Evidences of clinically definite oxidative stress:8-isoprostane,as a reliable biomarkers of lipid peroxidation | Posted | Mean | Standard Deviation | pg/ml | before induction, after clamping removal,operation ending,1,3,7days post surgery |
|
|
|
| Primary | Evidences of Clinically Definite Oxidative Stress:Micronuclei | Evidences of clinically definite oxidative stress:micronuclei confirmed by Cytokinesis-block Micronucleus Test | Posted | Mean | Standard Deviation | number of micronuclei/1000 BN cells | before induction,clamping removal ,operation ending,1,3,7days post surgery |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | ug/ml | before induction,after clamping removal ,operation ending ,1,3,7days post surgery |
|
|
|
| Primary | Evidences of Clinically Definite Oxidative Stress: Nuclear Buds | Evidences of clinically definite oxidative stress:nuclear buds Confirmed by Cytokinesis-block Micronucleus Test | Posted | Mean | Standard Deviation | number of nuclear buds/1000 BN cells | before induction,clamping removal ,operation ending,1,3,7days post surgery |
|
|
|
| Primary | Evidences of Clinically Definite Oxidative Stress: Nucleoplasmic Bridges | Evidences of clinically definite oxidative stress: nucleoplasmic bridges confirmed by Cytokinesis-block Micronucleus Test | Posted | Mean | Standard Deviation | number of nucleoplasmic bridges/1000 BN | before induction,clamping removal ,operation ending,1,3,7days post surgery |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | before induction,1,3,7days post surgery |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | before induction,1,3,7days post surgery |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Sevoflurane | 0.5%-2% sevoflurane sevoflurane: 0.5%-2% sevoflurane with BIS 40-60 | 0 | 30 | 0 | 30 |
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| D006846 |
| Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| 8-isoprostane of operation ending |
|
| 8-isoprostane of 1days post surgery |
|
| 8-isoprostane of 3days post surgery |
|
| 8-isoprostane of 7days post surgery |
|
| micronuclei of operation ending |
|
| micronuclei of 1days post surgery |
|
| micronuclei of 3days post surgery |
|
| micronuclei of 7days post surgery |
|
| α- tocopherol of opertaion ending |
|
| α- tocopherol of 1days post surgery |
|
| α- tocopherol of 3days post surgery |
|
| α- tocopherol of 7days post surgery |
|
| γ- tocopherol of before induction |
|
| γ- tocopherol of clamping removal |
|
| γ- tocopherol of opertaion ending |
|
| γ- tocopherol of 1days post surgery |
|
| γ- tocopherol of 3days post surgery |
|
| γ- tocopherol of 7days post surgery |
|
| nuclear buds of operation ending |
|
| nuclear buds of 1days post surgery |
|
| nuclear buds of 3days post surgery |
|
| nuclear buds of 7days post surgery |
|
| nucleoplasmic bridges of operation ending |
|
| nucleoplasmic bridges of 1days post surgery |
|
| nucleoplasmic bridges of 3days post surgery |
|
| nucleoplasmic bridges of 7days post surgery |
|
| 3 days post surgery of MMSE |
|
| 7 days post surgery of MMSE |
|
| 3days post surgery |
|
| 7days post surgery |
|