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The investigators want to evaluate the efficacy of the propofol and sevoflurane for the prevention of catheter-related bladder discomfort.
The mechanism of catheter-related bladder discomfort is thought to be related to the muscarinic receptor. Propofol and desflurane are most widely used as an anesthetic agent. Propofol and desflurane are known to block the muscarinic receptor in different ways.
The investigators want to evaluate the efficacy of the propofol and sevoflurane for the prevention of catheter-related bladder discomfort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propofol | Active Comparator | Propofol will be administered as the anesthetic maintenance agent. |
|
| Sevoflurane | Experimental | Sevoflurane will be administered as the anesthetic maintenance agent. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol | Drug | Propofol will be administered. |
| |
| Sevoflurane |
| Measure | Description | Time Frame |
|---|---|---|
| Catheter-related Bladder Discomfort | Catheter-related bladder discomfort will be measured at 1 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe). Patients with score >0 will be counted. | 1 hour postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Catheter-related Bladder Discomfort | Catheter-related bladder discomfort will be measured at 1 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe). Patients with score >0 will be counted. | 0, 6 and 24 hour postoperatively |
| Hemodynamic Parameters |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seolu National University of Hospital | Seoul | South Korea |
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| ID | Title | Description |
|---|---|---|
| FG000 | Propofol | Propofol will be administered as the anesthetic maintenance agent. Propofol: Propofol will be administered. |
| FG001 | Sevoflurane | Sevoflurane will be administered as the anesthetic maintenance agent. Sevoflurane: Sevoflurane will be administered. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Propofol | Propofol will be administered as the anesthetic maintenance agent. Propofol: Propofol will be administered. |
| BG001 | Sevoflurane | Sevoflurane will be administered as the anesthetic maintenance agent. Sevoflurane: Sevoflurane will be administered. |
| 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 | Catheter-related Bladder Discomfort | Catheter-related bladder discomfort will be measured at 1 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe). Patients with score >0 will be counted. | Patients with score >0 were counted. | Posted | Number | participants | 1 hour postoperatively |
|
0 h, 1 h, 6 h, 24 h, 6 month
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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 | Propofol | Propofol will be administered as the anesthetic maintenance agent. Propofol: Propofol will be administered. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Assistant professor | Keimyung university | +821028862876 | onidori1979@gmail.com |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D000077149 | Sevoflurane |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Drug |
Sevoflurane will be administered. |
|
Mean blood pressure and heart rate will be measured at 0, 1, 5, 10 minute postoperatively. Measurement at 10 minute means Mean blood pressure and heart rate at the admission of post-anesthetic care unit. |
| 0, 1, 5, 10 minute postoperatively |
| Nausea | Nausea will be measured at 0, 1, 6 and 24 hour postoperatively. | 0, 1, 6 and 24 hour postoperatively |
| Vomiting | Vomiting will be measured at 0, 1, 6 and 24 hour postoperatively. | 0, 1, 6 and 24 hour postoperatively |
| Dry Mouth | Dry mouth will be measured at 0, 1, 6 and 24 hour postoperatively. | 0, 1, 6 and 24 hour postoperatively |
| Flushing | Flushing will be measured at 0, 1, 6 and 24 hour postoperatively. | 0, 1, 6 and 24 hour postoperatively |
| Blurred Vision | Blurred vision will be measured at 0, 1, 6 and 24 hour postoperatively. | 0, 1, 6 and 24 hour postoperatively |
| Dizziness | Dizziness will be measured at 0, 1, 6 and 24 hour postoperatively. | 0, 1, 6 and 24 hour postoperatively |
| Analgesics | The amount of analgesics will be measured at 0, 1, 6 and 24 hour postoperatively. | 0, 1, 6 and 24 hour postoperatively |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Catheter-related Bladder Discomfort | Catheter-related bladder discomfort will be measured at 1 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe). Patients with score >0 will be counted. | Patients with score >0 will be counted. | Posted | Number | participants | 0, 6 and 24 hour postoperatively |
|
|
|
| Secondary | Hemodynamic Parameters | Mean blood pressure and heart rate will be measured at 0, 1, 5, 10 minute postoperatively. Measurement at 10 minute means Mean blood pressure and heart rate at the admission of post-anesthetic care unit. | Posted | Mean | Standard Deviation | mmHg | 0, 1, 5, 10 minute postoperatively |
|
|
|
| Secondary | Nausea | Nausea will be measured at 0, 1, 6 and 24 hour postoperatively. | Patients with nausea were counted. | Posted | Number | participants | 0, 1, 6 and 24 hour postoperatively |
|
|
|
| Secondary | Vomiting | Vomiting will be measured at 0, 1, 6 and 24 hour postoperatively. | Patients with vomiting were counted. | Posted | Number | participants | 0, 1, 6 and 24 hour postoperatively |
|
|
|
| Secondary | Dry Mouth | Dry mouth will be measured at 0, 1, 6 and 24 hour postoperatively. | Patients with dry mouth were counted. | Posted | Number | participants | 0, 1, 6 and 24 hour postoperatively |
|
|
|
| Secondary | Flushing | Flushing will be measured at 0, 1, 6 and 24 hour postoperatively. | Patients with flushing were counted. | Posted | Number | participants | 0, 1, 6 and 24 hour postoperatively |
|
|
|
| Secondary | Blurred Vision | Blurred vision will be measured at 0, 1, 6 and 24 hour postoperatively. | Patients with blurred vision were counted. | Posted | Number | participants | 0, 1, 6 and 24 hour postoperatively |
|
|
|
| Secondary | Dizziness | Dizziness will be measured at 0, 1, 6 and 24 hour postoperatively. | Patients with dizziness were counted. | Posted | Number | participants | 0, 1, 6 and 24 hour postoperatively |
|
|
|
| Secondary | Analgesics | The amount of analgesics will be measured at 0, 1, 6 and 24 hour postoperatively. | Patients infused with tramadol were counted. | Posted | Number | participants | 0, 1, 6 and 24 hour postoperatively |
|
|
|
| 0 |
| 41 |
| 0 |
| 41 |
| EG001 | Sevoflurane | Sevoflurane will be administered as the anesthetic maintenance agent. Sevoflurane: Sevoflurane will be administered. | 0 | 41 | 0 | 41 |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |