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Study Synopsis This protocol is formatted for ClinicalTrials.gov-style registration and manuscript-facing documentation. It is based on the uploaded Turkish ethics protocol and keeps the original core design: comparison of low-flow and minimal-flow sevoflurane anesthesia in robot-assisted laparoscopic radical prostatectomy.
Background and Rationale Robot-assisted laparoscopic radical prostatectomy (RALRP) is increasingly preferred for localized prostate cancer because of lower blood loss, reduced transfusion requirements, shorter hospitalization, and lower complication rates compared with open surgery. However, RALRP requires carbon dioxide pneumoperitoneum and steep Trendelenburg positioning, both of which may adversely affect respiratory mechanics, gas exchange, and hemodynamic stability.
Low-flow and minimal-flow anesthesia may improve humidification and warming of inspired gases, reduce inhalational agent consumption, decrease environmental waste, and potentially lower overall cost. Despite these theoretical and practical advantages, evidence remains limited regarding the physiologic safety and performance of minimal-flow sevoflurane anesthesia during long robotic pelvic surgery performed under pneumoperitoneum and steep Trendelenburg positioning.
Accordingly, this randomized prospective trial will compare low-flow (1 L/min) and minimal-flow (0.5 L/min) sevoflurane anesthesia during RALRP with respect to respiratory parameters, arterial blood gas values, intraoperative oxygenation variables, anesthetic consumption, and selected postoperative biochemical markers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-flow sevoflurane arm | Experimental | After tracheal intubation, fresh gas flow will be set at 1 L/min until MAC 1 is achieved. Thereafter, flow will be reduced to 0.5 L/min for maintenance. |
|
| Minimal-flow sevoflurane anesthesia | Experimental | Fresh gas flow 1 L/min after intubation until MAC 1 is achieved, then reduced to 0.5 L/min for maintenance anesthesia. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Common Anesthetic Management | Other | Standard intraoperative monitoring including BIS, pulse oximetry, temperature, and anesthesia workstation-derived respiratory variables.
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| Measure | Description | Time Frame |
|---|---|---|
| Arterial partial pressure of carbon dioxide (PaCOâ‚‚) | Comparison of arterial PaCOâ‚‚ values between the minimal-flow anesthesia group (0.5 L/min) and the low-flow anesthesia group (1 L/min) measured during robot-assisted laparoscopic radical prostatectomy. Arterial blood gas analysis will be performed at predefined intraoperative time points (T0: post-intubation, T1: before pneumoperitoneum, T2: after pneumoperitoneum and positioning, hourly during pneumoperitoneum, at the end of pneumoperitoneum, and before extubation). | intraoperative period, from post-intubation to before extubation on the day of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| End-tidal carbon dioxide (EtCOâ‚‚) | Comparison of end-tidal COâ‚‚ levels between the minimal-flow and low-flow anesthesia groups during surgery. | intraoperatively |
| Oxygenation parameters | Peripheral oxygen saturation (SpOâ‚‚) and arterial oxygen partial pressure (PaOâ‚‚) measured to evaluate intraoperative oxygenation. |
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Inclusion Criteria
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| Intraoperative period (T0-Text). |
| Inhalational anesthetic consumption | Total sevoflurane consumption recorded from the anesthesia machine at the end of surgery. | Postextubation |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |