Cerebral Hypoxia, Postoperative Cognitive Dysfunction
Conditions
Keywords
jugular bulb oxygen saturation, postoperative cognitive dysfunction, propofol, sevoflurane
Brief summary
the purpose of this study is to investigate whether propofol and sevoflurane have difference effect on cerebral oxygenation .
Detailed description
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.
Interventions
PROCEDUREpropofol
use total intravenous anesthesia with propofol
PROCEDUREsevoflurane
use inhalation anesthesia with sevoflurane
Sponsors
First Affiliated Hospital, Sun Yat-Sen University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* scheduled to take major surgery under general anesthesia over 18 years old classified as ASA class three or less
Exclusion criteria
* have a diagnosis of cerebrovascular disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the Incidence of Intraoperative Desaturation Between Propofol and Sevoflurane General Anesthesia | baseline ,every hour in the operation period,after extubation | 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%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the Incidence of Postoperative Cognitive Disfunction(POCD)Between Propofol and Sevoflurane General Anesthesia | 1-3days、5-7days after operation | 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. |
| 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 | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Vital Signs | baseline , evey hour in the operation,afte extubation | heart rate, artery blood pressure,pulse oxygen saturation,temperature |
| Blood Gas Analysis | baseline,every hour in the operation,after extubation | including artery blood and blood from jugular vein bulb |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Propofol-Abnormal patients with preoperative SjvO2\<55%
propofol: use total intravenous anesthesia with propofol | 32 |
| Propofol-Normal patients with preoperative SjvO2≥55%
propofol: use total intravenous anesthesia with propofol | 28 |
| Sevoflurane-Abnormal patients with preoperative SjvO2\<55%
sevoflurane: use inhalation anesthesia with sevoflurane | 31 |
| Sevoflurane-Normal patients with preoperative SjvO2≥55%
sevoflurane: use inhalation anesthesia with sevoflurane | 25 |
| Total | 116 |
Baseline characteristics
| Characteristic | Propofol-Abnormal | Propofol-Normal | Sevoflurane-Abnormal | Sevoflurane-Normal | Total |
|---|---|---|---|---|---|
| Age, Continuous | 63.5 years STANDARD_DEVIATION 7.6 | 69 years STANDARD_DEVIATION 10.5 | 64.2 years STANDARD_DEVIATION 8.3 | 67.2 years STANDARD_DEVIATION 8.5 | 65.7 years STANDARD_DEVIATION 8.6 |
| ASA ASA Ⅲ | 2 participants | 6 participants | 8 participants | 8 participants | 24 participants |
| ASA ASAⅡ | 30 participants | 22 participants | 23 participants | 17 participants | 92 participants |
| Sex: Female, Male Female | 9 Participants | 13 Participants | 8 Participants | 8 Participants | 38 Participants |
| Sex: Female, Male Male | 23 Participants | 15 Participants | 23 Participants | 17 Participants | 78 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 38 | 0 / 34 | 0 / 38 | 2 / 34 |
| serious Total, serious adverse events | 0 / 38 | 0 / 34 | 0 / 38 | 0 / 34 |
Outcome results
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%.
Time frame: baseline ,every hour in the operation period,after extubation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Propofol-Abnormal | the Incidence of Intraoperative Desaturation Between Propofol and Sevoflurane General Anesthesia | 17 participants |
| Propofol-Normal | the Incidence of Intraoperative Desaturation Between Propofol and Sevoflurane General Anesthesia | 6 participants |
| Sevoflurane-Abnormal | the Incidence of Intraoperative Desaturation Between Propofol and Sevoflurane General Anesthesia | 6 participants |
| Sevoflurane-Normal | the Incidence of Intraoperative Desaturation Between Propofol and Sevoflurane General Anesthesia | 0 participants |
Secondary
the Change in the Level of Serum BDNF(Brain-derived Neurotrophic Factor ) Between Propofol and Sevoflurane Anesthesia
Time frame: before anesthesia, after extubation ,1day after operation
Secondary
the Change in the Level of Serum s-100β Between Propofol and Sevoflurane Anesthesia
Time frame: before anesthesia,after extubation,1 day after operation
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.
Time frame: 1-3days、5-7days after operation
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Propofol-Abnormal | the Incidence of Postoperative Cognitive Disfunction(POCD)Between Propofol and Sevoflurane General Anesthesia | 1--3days after operation | 9 participants |
| Propofol-Abnormal | the Incidence of Postoperative Cognitive Disfunction(POCD)Between Propofol and Sevoflurane General Anesthesia | 5-7 days after operation | 5 participants |
| Propofol-Normal | the Incidence of Postoperative Cognitive Disfunction(POCD)Between Propofol and Sevoflurane General Anesthesia | 5-7 days after operation | 2 participants |
| Propofol-Normal | the Incidence of Postoperative Cognitive Disfunction(POCD)Between Propofol and Sevoflurane General Anesthesia | 1--3days after operation | 4 participants |
| Sevoflurane-Abnormal | the Incidence of Postoperative Cognitive Disfunction(POCD)Between Propofol and Sevoflurane General Anesthesia | 1--3days after operation | 4 participants |
| Sevoflurane-Abnormal | the Incidence of Postoperative Cognitive Disfunction(POCD)Between Propofol and Sevoflurane General Anesthesia | 5-7 days after operation | 4 participants |
| Sevoflurane-Normal | the Incidence of Postoperative Cognitive Disfunction(POCD)Between Propofol and Sevoflurane General Anesthesia | 1--3days after operation | 8 participants |
| Sevoflurane-Normal | the Incidence of Postoperative Cognitive Disfunction(POCD)Between Propofol and Sevoflurane General Anesthesia | 5-7 days after operation | 4 participants |
Other Pre-specified
Blood Gas Analysis
including artery blood and blood from jugular vein bulb
Time frame: baseline,every hour in the operation,after extubation
Other Pre-specified
Vital Signs
heart rate, artery blood pressure,pulse oxygen saturation,temperature
Time frame: baseline , evey hour in the operation,afte extubation