Postoperative Cognitive Dysfunction
Conditions
Keywords
Postoperative cognitive dysfunction, elderly patients, long surgery
Brief summary
Various issues had been pointed out when undergoing the anesthesia for elderly patients with sevoflurane, such as delayed emergence, post-operative trouble with swallowing. Desflurane, which has a lower blood/gas partition coefficient, is expected to contribute the better emergence, along with the recent progress on optimization of delivered amount of anesthesia. The purpose of this study is to compare the time to emergence in long elderly patient cases with desflurane or sevoflurane, with the recently developed drug-delivery optimization system Aisys® (GE Healthcare Japan).
Detailed description
The objectives of this study is to compare the time to emergence and quality of recovery in long elderly patient cases with desflurane or sevoflurane, with the recently developed drug-delivery optimization system Aisys® (GE Healthcare Japan). Inclusion Criteria: \- Elderly patients (\>= 65 yr-old), long operation (\> 4hours), abdominal surgery patients Exclusion Criteria: \- Liver dysfunction, Renal dysfunction, preoperative dementia Neurosurgery patients, Cardiac surgery patients, obese patients(BMI\>35)
Interventions
DRUGDesflurane
The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.
DRUGSevoflurane
The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
Sponsors
Sapporo Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Elderly patients (\>= 65 yr-old), long operation (\> 4hours), abdominal surgery patients
Exclusion criteria
\- Liver dysfunction, Renal dysfunction, preoperative dementia Neurosurgery patients, Cardiac surgery patients, obese patients(BMI\>35)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Time From the End of Anesthesia to Extubation | Within 60 minutes after the end of anesthesia | When surgery ends, the fresh gas flow rate will be increased to 6L/min (100% oxygen). Patients will be asked to open eyes by touching the shoulder, calling the name every 15 seconds. Patients will be applied stimulus every 15 seconds until following commands. Extubation will be performed when the patient is judged to be awake and spontaneous breathing recovery substantially. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Time From the End of Anesthesia to Eye Opening | Within 60 minutes after the end of anesthesia | When surgery ends, the fresh gas flow rate will be increased to 6L/min (100% oxygen). Patients will be asked to open eyes by touching the shoulder, calling the name every 15 seconds. Patients will be applied stimulus every 15 seconds until following commands. Extubation will be performed when the patient is judged to be awake and spontaneous breathing recovery substantially. |
| The Time From the End of Anesthesia to Following Commands | Within 60 minutes after the end of anesthesia | When surgery ends, the fresh gas flow rate will be increased to 6L/min (100% oxygen). Patients will be asked to open eyes by touching the shoulder, calling the name every 15 seconds. Patients will be applied stimulus every 15 seconds until following commands. Extubation will be performed when the patient is judged to be awake and spontaneous breathing recovery substantially. |
| Cognitive Function | 24 hrs pre and postoperatively | Cognitive function will be measured by MMSE (Mini-Mental State Examination) at 24hrs pre and postoperatively. Total MMSE score is recorded by interview ranging from 0 (minimum) to 30 (maximum). MMSE score is consisted on 11 subscales, and total MMSE score is simply summation of all the subscale scores. Maximum MMSE score indicates that the patient is excellent for cognitive function. MMSE score under 26 indicated the cognitive dysfunction. |
| The Incidence of Postoperative Delirium | from 15 minutes to 48 hrs postoperatively | The incidence of post operative delirium will be measured by Confusion Assessment Method (CAM) at baseline, 15mins, 3hrs, 6hrs, 12hrs, 24hrs, 48hrs postoperatively. |
Countries
Japan
Participant flow
Recruitment details
Twenty patients who were scheduled to undergo general anesthesia in Sapporo Medical University Hospital were enrolled in this study.
Pre-assignment details
Inclusion criteria were shown as follows: Elderly patients (\>= 65 yr-old), long operation (\> 4hours), abdominal surgery patients. Exclusion criteria were shown as follows: Liver dysfunction, Renal dysfunction, preoperative dementia Neurosurgery patients, Cardiac surgery patients, obese patients (BMI\>35)
Participants by arm
| Arm | Count |
|---|---|
| Group DES The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine. | 10 |
| Group SEVO The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Group SEVO | Group DES | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 10 Participants | 20 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 74.1 years STANDARD_DEVIATION 6.5 | 74.9 years STANDARD_DEVIATION 6 | 74.5 years STANDARD_DEVIATION 6.1 |
| Region of Enrollment Japan | 10 participants | 10 participants | 20 participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
The Time From the End of Anesthesia to Extubation
When surgery ends, the fresh gas flow rate will be increased to 6L/min (100% oxygen). Patients will be asked to open eyes by touching the shoulder, calling the name every 15 seconds. Patients will be applied stimulus every 15 seconds until following commands. Extubation will be performed when the patient is judged to be awake and spontaneous breathing recovery substantially.
Time frame: Within 60 minutes after the end of anesthesia
Population: This is a pilot study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group DES | The Time From the End of Anesthesia to Extubation | 329.0 second |
| Group SEVO | The Time From the End of Anesthesia to Extubation | 636.0 second |
Secondary
Cognitive Function
Cognitive function will be measured by MMSE (Mini-Mental State Examination) at 24hrs pre and postoperatively. Total MMSE score is recorded by interview ranging from 0 (minimum) to 30 (maximum). MMSE score is consisted on 11 subscales, and total MMSE score is simply summation of all the subscale scores. Maximum MMSE score indicates that the patient is excellent for cognitive function. MMSE score under 26 indicated the cognitive dysfunction.
Time frame: 24 hrs pre and postoperatively
Population: This is a pilot study
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group DES | Cognitive Function | pre-operation | 28.0 Scores on a scale |
| Group DES | Cognitive Function | post-operation | 29.5 Scores on a scale |
| Group SEVO | Cognitive Function | pre-operation | 28.0 Scores on a scale |
| Group SEVO | Cognitive Function | post-operation | 29.0 Scores on a scale |
Secondary
The Incidence of Postoperative Delirium
The incidence of post operative delirium will be measured by Confusion Assessment Method (CAM) at baseline, 15mins, 3hrs, 6hrs, 12hrs, 24hrs, 48hrs postoperatively.
Time frame: from 15 minutes to 48 hrs postoperatively
Population: This is a pilot study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group DES | The Incidence of Postoperative Delirium | 2 participants |
| Group SEVO | The Incidence of Postoperative Delirium | 0 participants |
Secondary
The Time From the End of Anesthesia to Eye Opening
When surgery ends, the fresh gas flow rate will be increased to 6L/min (100% oxygen). Patients will be asked to open eyes by touching the shoulder, calling the name every 15 seconds. Patients will be applied stimulus every 15 seconds until following commands. Extubation will be performed when the patient is judged to be awake and spontaneous breathing recovery substantially.
Time frame: Within 60 minutes after the end of anesthesia
Population: This is a pilot study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group DES | The Time From the End of Anesthesia to Eye Opening | 176.5 second |
| Group SEVO | The Time From the End of Anesthesia to Eye Opening | 315.0 second |
Secondary
The Time From the End of Anesthesia to Following Commands
When surgery ends, the fresh gas flow rate will be increased to 6L/min (100% oxygen). Patients will be asked to open eyes by touching the shoulder, calling the name every 15 seconds. Patients will be applied stimulus every 15 seconds until following commands. Extubation will be performed when the patient is judged to be awake and spontaneous breathing recovery substantially.
Time frame: Within 60 minutes after the end of anesthesia
Population: This is a pilot study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group DES | The Time From the End of Anesthesia to Following Commands | 246.5 second |
| Group SEVO | The Time From the End of Anesthesia to Following Commands | 424.0 second |