Clinical trial · Interventional
Low-flow Versus Minimal-flow Sevoflurane Anesthesia During Robot-assisted Laparoscopic Radical Prostatectomy
A Prospective Randomized Study Comparing Low-Flow (1 L/Min) and Minimal-Flow (0.5 L/Min) Sevoflurane Anesthesia in Patients Undergoing Robot-Assisted Laparoscopic Radical Prostatectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anesthesia | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Respiratory Mechanics | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Common Anesthetic Management | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Low-flow sevoflurane arm
- description
- 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.
- interventionNames
- Other: Common Anesthetic Management
- type
- EXPERIMENTAL
- label
- Minimal-flow sevoflurane anesthesia
- description
- Fresh gas flow 1 L/min after intubation until MAC 1 is achieved, then reduced to 0.5 L/min for maintenance anesthesia.
- interventionNames
- Other: Common Anesthetic Management
Primary outcomes (1)
- measure
- Arterial partial pressure of carbon dioxide (PaCO₂)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Male patients aged 18 years or older. * ASA physical status I-II. * Scheduled for elective robot-assisted laparoscopic radical prostatectomy. * Provision of written informed consent. Exclusion Criteria * ASA physical status III-V. * Severe cardiac, respiratory, hepatic, or renal disease. * Mental status disorder or significant hearing impairment that prevents consent or communication. * Known anxiety, depression, or other psychiatric disorder judged to interfere with study participation. * Withdrawal of consent or investigator decision for safety reasons.
References
Publications (0)
Data not yet available