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The investigators hypothesized that both propofol and desflurane would decrease the regional oxygen saturation (rSO2) but propofol is likely to reduce rSO2 more than sevoflurane when patients are raised to the sitting position.
The investigators hypothesized that both propofol and desflurane would decrease the rSO2 but propofol is likely to reduce rSO2 more than sevoflurane when patients are raised to the sitting position. Therefore, the purpose of this study was to investigate the effect of desflurane and propofol on rSO2 values during the beach chair position for shoulder arthroscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Desflurane | Experimental | anaesthesia was induced with thiopental sodium 2 mg kg-1, alfentanil 10 μg kg-1 and rocuronium 0.6 mg kg-1. Anesthetic maintenance by desflurane |
|
| propofol | Active Comparator | anaesthesia was induced with the effect-site concentration of propofol 5.0 μg ml-1, alfentanil 10 μg kg-1, and rocuronium 0.6 mg kg-1. A commercially available target controlled infusion (TCI) pump (Orchestra®, Fresenius Vial, France) was used and the pharmacokinetic set used to calculate target effect-site concentrations for propofol was Schnider and colleagues' model |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| propofol | Drug | anaesthesia was induced with the effect-site concentration of propofol 5.0 μg ml-1 mainly. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Regional Cerebral Oxygen Satuation (rSO2) | definitive values of regional cerebral oxygen saturation(rSO2,%) values are described as mean (SD) | 1, 3, 5, 7, and 9 min after the beach chair position |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hyun Jeong Kwak, MD.PhD | Gachon University Gil Medical Center | Study Director |
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no enrolled participants were excluded.
March 2011-August 2011 in Gachon University Gil Medical Center, who underwent arthroscopic shoulder surgery
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| ID | Title | Description |
|---|---|---|
| FG000 | Desflurane | anaesthesia was induced with thiopental sodium 2 mg kg-1, alfentanil 10 μg kg-1 and rocuronium 0.6 mg kg-1. Anesthetic maintenance by desflurane |
| FG001 | Propofol | anaesthesia was induced with the effect-site concentration of propofol 5.0 μg ml-1, alfentanil 10 μg kg-1, and rocuronium 0.6 mg kg-1. A commercially available target controlled infusion (TCI) pump (Orchestra®, Fresenius Vial, France) was used and the pharmacokinetic set used to calculate target effect-site concentrations for propofol was Schnider and colleagues' model |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Desflurane | anaesthesia was induced with thiopental sodium 2 mg kg-1, alfentanil 10 μg kg-1 and rocuronium 0.6 mg kg-1. Anesthetic maintenance by desflurane |
| BG001 | Propofol | anaesthesia was induced with the effect-site concentration of propofol 5.0 μg ml-1, alfentanil 10 μg kg-1, and rocuronium 0.6 mg kg-1. A commercially available target controlled infusion (TCI) pump (Orchestra®, Fresenius Vial, France) was used and the pharmacokinetic set used to calculate target effect-site concentrations for propofol was Schnider and colleagues' model |
| 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 | Regional Cerebral Oxygen Satuation (rSO2) | definitive values of regional cerebral oxygen saturation(rSO2,%) values are described as mean (SD) | A power analysis was calculated based on a previous study.14 In each group, 16 patients were needed to detect a mean intergroup difference of 5% in the rSO2 value with a power of 80% and a type I error of 0.05. To compensate for a dropout rate of 20%, 40 patients were included in this study. | Posted | Mean | Standard Deviation | percentage of rSO2 (%) | 1, 3, 5, 7, and 9 min after the beach chair position |
|
1, 3, 5, 7 and 9 min after the sitting position and postoperative 24hours
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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 | Desflurane | anaesthesia was induced with thiopental sodium 2 mg kg-1, alfentanil 10 μg kg-1 and rocuronium 0.6 mg kg-1. Anesthetic maintenance by desflurane |
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limitations of this study is that the ventilation was adjusted according to ETCO2 value instead of the arterial carbon dioxide tensions (PaCO2).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.HJ Kwak | Gachon University Gil Medical Center | 82-32-460-3400 | hyun615@gilhospital.com |
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| ID | Term |
|---|---|
| D002545 | Brain Ischemia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D000077335 | Desflurane |
| D003893 | Desmin |
| D015760 | Alfentanil |
| C119951 | GTF2A1L protein, human |
| D000077123 | Rocuronium |
| D012372 | ROC Curve |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Desflurane | Drug | anaesthesia was maintained by desflurane 4-7vol% |
|
|
| alfentanil | Drug | administration of alfentanil 10 μg kg-1 for anesthetic induction |
|
|
| Rocuronium | Drug | administration of rocuronium 0.6 mg kg-1 for anesthetic induction |
|
|
| 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 |
|
anesthetic maintanence with propofol
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Propofol | anaesthesia was induced with the effect-site concentration of propofol 5.0 μg ml-1, alfentanil 10 μg kg-1, and rocuronium 0.6 mg kg-1. A commercially available target controlled infusion (TCI) pump (Orchestra®, Fresenius Vial, France) was used and the pharmacokinetic set used to calculate target effect-site concentrations for propofol was Schnider and colleagues' model | 0 | 20 | 0 | 20 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D005019 | Ethyl Ethers |
| D004987 | Ethers |
| D008738 | Methyl Ethers |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D007381 | Intermediate Filament Proteins |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D003598 | Cytoskeletal Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D012680 | Sensitivity and Specificity |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D013223 | Statistics as Topic |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |