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the purpose of this study is to investigate whether propofol and sevoflurane have difference effect on cerebral oxygenation .
the purpose of this study:(1) to investigate the incidence of preoperative cerebral oxygenation abnormity (SjvO2 <55%) and its relationship with intraoperative cerebral desaturation and POCD. (2) To investigate the change of intraoperative cerebral oxygen supply and demand balance and the incidence of cerebral desaturation in patients with abnormal preoperative cerebral oxygenation during sevoflurane anesthesia. (3)To investigate the incidence of early POCD in patients with abnormal preoperative cerebral oxygenation during sevoflurane and propofol anesthesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propofol-Abnormal | patients with preoperative SjvO2<55%,using the TIVA technology with propofol, |
| |
| Propofol-Normal | patients with preoperative SjvO2≥55%,using the TIVA technology with propofol, |
| |
| Sevoflurane-Abnormal | patients with preoperative SjvO2<55%,using the VIMA technology with sevoflurane, |
| |
| Sevoflurane-Normal | patients with preoperative SjvO2≥55%,using the VIMA technology with sevoflurane, |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| propofol | Procedure | use total intravenous anesthesia with propofol |
|
| Measure | Description | Time Frame |
|---|---|---|
| the Incidence of Intraoperative Desaturation Between Propofol and Sevoflurane General Anesthesia | SjvO2 were measured before anesthesia, after intubation, every hour during operation, after extubation by jugular vein blood and atrial blood gas analysis.The incidence of intraoperative cerebral desaturation was recorded when SjvO2<50%. | baseline ,every hour in the operation period,after extubation |
| Measure | Description | Time Frame |
|---|---|---|
| the Incidence of Postoperative Cognitive Disfunction(POCD)Between Propofol and Sevoflurane General Anesthesia | The incidence of early POCD was recorded. The MMSE score and the Montreal cognitive assessment (MoCA) score were recorded 1day before surgery, 1-3 day after surgery and 5-7 day after surgery. The POCD was defined as MMSE score illiterate group ≤ 17, primary and secondary school group ≤ 20, junior high school and above group ≤ 24，or the MoCA score decreased 20% with the baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Vital Signs | heart rate, artery blood pressure,pulse oxygen saturation,temperature | baseline , evey hour in the operation,afte extubation |
| Blood Gas Analysis | including artery blood and blood from jugular vein bulb |
Inclusion Criteria:
Exclusion Criteria:
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Adult patients undergoing elective major surgery
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| Name | Affiliation | Role |
|---|---|---|
| Guo J Ying, Master | the First Affiliated Hospital of SunYetSen University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital of Sun YetSen University | Guangzhou | Guangdong | 510080 | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | Propofol-Abnormal | patients with preoperative SjvO2<55% propofol: use total intravenous anesthesia with propofol |
| FG001 | Propofol-Normal | patients with preoperative SjvO2≥55% propofol: use total intravenous anesthesia with propofol |
| FG002 | Sevoflurane-Abnormal | patients with preoperative SjvO2<55% sevoflurane: use inhalation anesthesia with sevoflurane |
| FG003 | Sevoflurane-Normal | patients with preoperative SjvO2≥55% sevoflurane: use inhalation anesthesia with sevoflurane |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Propofol-Abnormal | patients with preoperative SjvO2<55% propofol: use total intravenous anesthesia with propofol |
| BG001 | Propofol-Normal | patients with preoperative SjvO2≥55% propofol: use total intravenous anesthesia with propofol |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | the Incidence of Intraoperative Desaturation Between Propofol and Sevoflurane General Anesthesia | SjvO2 were measured before anesthesia, after intubation, every hour during operation, after extubation by jugular vein blood and atrial blood gas analysis.The incidence of intraoperative cerebral desaturation was recorded when SjvO2<50%. | Posted | Number | participants | baseline ,every hour in the operation period,after extubation |
|
the day of surgery and 1 week after surgery
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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-Abnormal | patients with preoperative SjvO2<55% propofol: use total intravenous anesthesia with propofol |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| heart failure | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| allergy | Immune system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Juan-ying Guo | FirstSunYetSen | 8602087755766(8273) | gjunying@aliyun.com |
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| ID | Term |
|---|---|
| D002534 | Hypoxia, Brain |
| D000079690 | Postoperative Cognitive Complications |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000860 | Hypoxia |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D000077149 | Sevoflurane |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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serum
| sevoflurane | Procedure | use inhalation anesthesia with sevoflurane |
|
| 1-3days、5-7days after operation |
| the Change in the Level of Serum BDNF(Brain-derived Neurotrophic Factor ) Between Propofol and Sevoflurane Anesthesia | before anesthesia, after extubation ,1day after operation |
| the Change in the Level of Serum s-100β Between Propofol and Sevoflurane Anesthesia | before anesthesia,after extubation,1 day after operation |
| baseline,every hour in the operation,after extubation |
| BG002 | Sevoflurane-Abnormal | patients with preoperative SjvO2<55% sevoflurane: use inhalation anesthesia with sevoflurane |
| BG003 | Sevoflurane-Normal | patients with preoperative SjvO2≥55% sevoflurane: use inhalation anesthesia with sevoflurane |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ASA | ASA I No organic, physiologic, biochemical or psychiatric disturbance ASA II A patient with mild systemic disease that results in no functional limitation. Examples: well-controlled hypertension, uncomplicated diabetes mellitus. ASA III A patient with severe systemic disease that results in functional impairment ASA IV Severe systemic disease that is a constant threat to life. ASA V Moribund condition in a patient who is not expected to survive with or without the operation. ASA VI Declared brain death patient whose organs are being harvested for transplantation. | Number | participants |
|
| OG002 | Sevoflurane-Abnormal | patients with preoperative SjvO2<55% sevoflurane: use inhalation anesthesia with sevoflurane |
| OG003 | Sevoflurane-Normal | patients with preoperative SjvO2≥55% sevoflurane: use inhalation anesthesia with sevoflurane |
|
|
| Secondary | the Incidence of Postoperative Cognitive Disfunction(POCD)Between Propofol and Sevoflurane General Anesthesia | The incidence of early POCD was recorded. The MMSE score and the Montreal cognitive assessment (MoCA) score were recorded 1day before surgery, 1-3 day after surgery and 5-7 day after surgery. The POCD was defined as MMSE score illiterate group ≤ 17, primary and secondary school group ≤ 20, junior high school and above group ≤ 24，or the MoCA score decreased 20% with the baseline. | Posted | Number | participants | 1-3days、5-7days after operation |
|
|
|
| Secondary | the Change in the Level of Serum BDNF(Brain-derived Neurotrophic Factor ) Between Propofol and Sevoflurane Anesthesia | Not Posted | before anesthesia, after extubation ,1day after operation |
| Secondary | the Change in the Level of Serum s-100β Between Propofol and Sevoflurane Anesthesia | Not Posted | before anesthesia,after extubation,1 day after operation |
| Other Pre-specified | Vital Signs | heart rate, artery blood pressure,pulse oxygen saturation,temperature | Not Posted | baseline , evey hour in the operation,afte extubation |
| Other Pre-specified | Blood Gas Analysis | including artery blood and blood from jugular vein bulb | Not Posted | baseline,every hour in the operation,after extubation |
| 0 |
| 38 |
| 1 |
| 38 |
| EG001 | Propofol-Normal | patients with preoperative SjvO2≥55% propofol: use total intravenous anesthesia with propofol | 0 | 34 | 0 | 34 |
| EG002 | Sevoflurane-Abnormal | patients with preoperative SjvO2<55% sevoflurane: use inhalation anesthesia with sevoflurane | 0 | 38 | 0 | 38 |
| EG003 | Sevoflurane-Normal | patients with preoperative SjvO2≥55% sevoflurane: use inhalation anesthesia with sevoflurane | 0 | 34 | 2 | 34 |
| pulmonary edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D012818 |
| Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D060825 | Cognitive Dysfunction |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| 5-7 days after operation |
|