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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).
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group DES | Active Comparator | The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine. |
|
| group SEVO | Active Comparator | The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desflurane | Drug | The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 60 minutes after the end of anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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)
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| Name | Affiliation | Role |
|---|---|---|
| Michiaki Yamakage, M.D.,PhD | Sapporo Medical University, School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sapporo Medical University, School of Medicine | Sappro | Hokkaido | 0608556 | Japan |
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)
Twenty patients who were scheduled to undergo general anesthesia in Sapporo Medical University Hospital were enrolled in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group DES | The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine. |
| FG001 | Group SEVO | The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group DES | The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine. |
| BG001 | Group SEVO | The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine. |
| 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 | 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. | This is a pilot study. | Posted | Median | Inter-Quartile Range | second | Within 60 minutes after the end of anesthesia |
|
The adverse event will be evaluated at 24 h after surgery by interviewing.
The adverse event is defined as follows: postoperative death, re-operation, hypotension (systolic blood pressure under 80 mmHg), and delirium at 24 h after surgery. If the adverse event occur and recover until 24 h after surgery, the adverse event is not counted. Other adverse event is not assessed.
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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 | Group DES | The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michiaki Yamakage | Sapporo Medical University School of Medicine | +81116112111 | 3568 | yamakage@sapmed.ac.jp |
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| ID | Term |
|---|---|
| D000079690 | Postoperative Cognitive Complications |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D060825 | Cognitive Dysfunction |
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| ID | Term |
|---|---|
| D000077335 | Desflurane |
| D000077149 | Sevoflurane |
| ID | Term |
|---|---|
| D005019 | Ethyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D008738 | Methyl Ethers |
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| Sevoflurane | Drug | The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine. |
|
|
| Within 60 minutes after the end of anesthesia |
| 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. | Within 60 minutes after the end of anesthesia |
| 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. | 24 hrs pre and postoperatively |
| 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. | from 15 minutes to 48 hrs postoperatively |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine. |
|
|
| 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. | This is a pilot study. | Posted | Median | Inter-Quartile Range | second | Within 60 minutes after the end of anesthesia |
|
|
|
| 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. | This is a pilot study. | Posted | Median | Inter-Quartile Range | second | Within 60 minutes after the end of anesthesia |
|
|
|
| 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. | This is a pilot study | Posted | Median | Inter-Quartile Range | Scores on a scale | 24 hrs pre and postoperatively |
|
|
|
| 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. | This is a pilot study. | Posted | Number | participants | from 15 minutes to 48 hrs postoperatively |
|
|
|
| 0 |
| 10 |
| 0 |
| 0 |
| EG001 | Group SEVO | The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine. | 0 | 10 | 0 | 0 |
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| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |