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To assess the effectiveness of two anesthetic techniques by measuring the pain through visual analog scale (VAS), to obtain saturation prostate biopsies.
To assess the effectiveness of two anesthetic techniques by measuring the pain through visual analog scale (VAS), to obtain saturation prostate biopsies.
Anesthetic technique (control) - Intravenous sedation with Midazolam, Fentanile and Ketamine.
Anesthetic technique (intervention) - Regional Mepivacaine infiltration of periprostatic region.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CONTROL | Active Comparator | Saturation prostate biopsy under intravenous sedation MIDAZOLAM 1,5 mg per kilogram intravenous, 5 minutes prior to biopsy FENTANILE 0,05 mg per kilogram intravenous, 3 minutes prior to biopsy KETAMINE 0.5 mg per kilogram intravenous, 1 minute prior to biopsy |
|
| EXPERIMENTAL | Experimental | Saturation prostate biopsy under local anesthesia MEPIVACAÍNE 2% 10 millimeters periprostatic block at base and ápex, bilaterally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MIDAZOLAM | Drug | Intravenous bolus anesthesia 5 minutes previous to saturation prostate biopsy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in visual analog scale (VAS) | Change in visual analog scale (VAS) from baseline and after prostate biopsy | 1 hour baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with complications after anesthesic procedure and prostate biopsy procedure, after 24 hours of the procedure and at end of study visit. All units will be measured as numbers. | To assess the safety of the procedure and complications in the use of each of the anesthetic techniques during saturation prostate biopsy. Safety events will be measured during saturation prostate biopsy and after recovery, during 24 hours. Number of patients with complications after anesthesic procedure and prostate biopsy procedure. Number of patients with complications after 24 hours of the procedure. Number of patients with complications at end of study visit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose L Ponce, MD | Complejo Hospitalario Universitario, A Coruña | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jose Luis Ponce Diaz-Reixa | A Coruña | 15006 | Spain |
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| MEPIVACAÍNE | Drug | Local periprostatic anesthesia infiltration, previous to saturation prostate biopsy. |
|
|
| FENTANILE | Drug | Intravenous bolus anesthesia 3 minutes previous to saturation prostate biopsy. |
|
|
| KETAMINE | Drug | Intravenous bolus anesthesia 1 minute previous to saturation prostate biopsy. |
|
|
| One week |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D010146 | Pain |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D008619 | Mepivacaine |
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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