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| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
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Which is more adequate general anesthetic agent, desflurane or propofol, for emergence and recovery time, and perioperative oxygenation in lung resection surgery?
The investigators plan to investigate the effects of desflurane on oxygenation (prevention of HPV) of OLV compare with propofol which is used in general anesthesia for lung resection.
Transesophageal echocardiography (TEE) wiill be used to measure pulmonary blood flow during surgery visible and successively. To confirm the effect of HPV by measuring the change in pulmonary blood flow. The correlation between the blood oxygen concentration and attenuation of blood flow will be investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Desflurane | Active Comparator | Desflurane group: this group of patients receives desflurane as the main anesthetic agent in addition to remifentanil infusion at 0.1~0.3 mcg/kg/min during one-lung anesthesia. Bispectral index will be maintained between 45 and 50. Arterial blood gases and pulmonary blood flow by using tansesphageal echocardiogrphy will be measured. |
|
| Propofol | Active Comparator | Propofol group: this group of patients receives propofol as the main anesthetic agent in addition to remifentanil infusion at the rate of 0.1~0.3 mcg./g/min during one-lung anesthesia. Bispectral index will be maintained between 45 and 50. Arterial blood gases and pulmonary blood flow by using tansesphageal echocardiogrphy will be measured. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| desflurane | Drug | Desflurane group: this group of patients receives desflurane as the main anesthetic agent during one-lung anesthesia. Propofol group: this group of patients receives propofol as the main anesthetic agnet during on-lung anesthesia. |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygenation | Arterial blood gases are monitored.Pulmonary blood flow is measured using transesophageal echocardiogram. | prior to surgery to one-hour after extubation |
| Measure | Description | Time Frame |
|---|---|---|
| Rapidity of Emergence From Anesthesia | Time to extubation and orientation, where the patient is. | one minute after cessation of anethetic agents to one hour after extubation |
| Quality of Consiousness |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eiichi Inada, M.D. | Juntendo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Juntendo | Bunkyō City | Tokyko | 113-8421 | Japan |
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| ID | Title | Description |
|---|---|---|
| FG000 | Desflurane | Desflurane group: this group of patients receives desflurane as the main anesthetic agent in addition to remifentanil infusion at 0.1~0.3 mcg/kg/min during one-lung anesthesia. Bispectral index will be maintained between 45 and 50. Arterial blood gases and pulmonary blood flow by using tansesphageal echocardiogrphy will be measured. desflurane: Desflurane group: this group of patients receives desflurane as the main anesthetic agent during one-lung anesthesia. Propofol group: this group of patients receives propofol as the main anesthetic agnet during on-lung anesthesia. |
| FG001 | Propofol | Propofol group: this group of patients receives propofol as the main anesthetic agent in addition to remifentanil infusion at the rate of 0.1~0.3 mcg./g/min during one-lung anesthesia. Bispectral index will be maintained between 45 and 50. Arterial blood gases and pulmonary blood flow by using tansesphageal echocardiogrphy will be measured. propofol: Propofol group:this group of patients receives propofol as the main anesthetic agent during one-lung anesthesia. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Desflurane | Desflurane group: this group of patients receives desflurane as the main anesthetic agent in addition to remifentanil infusion at 0.1~0.3 mcg/kg/min during one-lung anesthesia. Bispectral index will be maintained between 45 and 50. Arterial blood gases and pulmonary blood flow by using tansesphageal echocardiogrphy will be measured. desflurane: Desflurane group: this group of patients receives desflurane as the main anesthetic agent during one-lung anesthesia. Propofol group: this group of patients receives propofol as the main anesthetic agnet during on-lung anesthesia. |
| 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 | Oxygenation | Arterial blood gases are monitored.Pulmonary blood flow is measured using transesophageal echocardiogram. | Posted | Mean | Standard Deviation | mmHg | prior to surgery to one-hour after extubation |
|
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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 | Desflurane group: this group of patients receives desflurane as the main anesthetic agent in addition to remifentanil infusion at 0.1~0.3 mcg/kg/min during one-lung anesthesia. Bispectral index will be maintained between 45 and 50. Arterial blood gases and pulmonary blood flow by using tansesphageal echocardiogrphy will be measured. desflurane: Desflurane group: this group of patients receives desflurane as the main anesthetic agent during one-lung anesthesia. Propofol group: this group of patients receives propofol as the main anesthetic agnet during on-lung anesthesia. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Izumi Kawagoe | Juntendo University | +81338133111 | ikawago@juntendo.ac.jp |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077335 | Desflurane |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D005019 | Ethyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D008738 | Methyl Ethers |
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|
| propofol | Drug | Propofol group:this group of patients receives propofol as the main anesthetic agent during one-lung anesthesia. |
|
|
quality of consciousness will be assessed using Aldrete score
| after extubation |
| Postoperative Nausea and Vomiting | degree of nausea and frequency of vomiting | on the postoperative day 1 |
| BG001 | Propofol | Propofol group: this group of patients receives propofol as the main anesthetic agent in addition to remifentanil infusion at the rate of 0.1~0.3 mcg./g/min during one-lung anesthesia. Bispectral index will be maintained between 45 and 50. Arterial blood gases and pulmonary blood flow by using tansesphageal echocardiogrphy will be measured. propofol: Propofol group:this group of patients receives propofol as the main anesthetic agent during one-lung anesthesia. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Propofol |
Propofol group: this group of patients receives propofol as the main anesthetic agent in addition to remifentanil infusion at the rate of 0.1~0.3 mcg./g/min during one-lung anesthesia. Bispectral index will be maintained between 45 and 50. Arterial blood gases and pulmonary blood flow by using tansesphageal echocardiogrphy will be measured. propofol: Propofol group:this group of patients receives propofol as the main anesthetic agent during one-lung anesthesia. |
|
|
| Secondary | Rapidity of Emergence From Anesthesia | Time to extubation and orientation, where the patient is. | Posted | Mean | Standard Deviation | seconds | one minute after cessation of anethetic agents to one hour after extubation |
|
|
|
| Secondary | Quality of Consiousness | quality of consciousness will be assessed using Aldrete score | number of the patients who cannot achieve full consciousness in Aldlete score 5min after extubation | Posted | Number | participants | after extubation |
|
|
|
| Secondary | Postoperative Nausea and Vomiting | degree of nausea and frequency of vomiting | the number of patients who encountered PONV for 24 hours after surgery. | Posted | Count of Participants | Participants | on the postoperative day 1 |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Propofol | Propofol group: this group of patients receives propofol as the main anesthetic agent in addition to remifentanil infusion at the rate of 0.1~0.3 mcg./g/min during one-lung anesthesia. Bispectral index will be maintained between 45 and 50. Arterial blood gases and pulmonary blood flow by using tansesphageal echocardiogrphy will be measured. propofol: Propofol group:this group of patients receives propofol as the main anesthetic agent during one-lung anesthesia. | 0 | 40 | 0 | 40 | 0 | 40 |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |