Low-flow Versus Minimal-flow Sevoflurane Anesthesia During Robot-assisted Laparoscopic Radical Prostatectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Common Anesthetic Management.
- Who it may be relevant to
- Registry conditions: Prostate Cancer, Anesthesia, Respiratory Mechanics. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Other Common Anesthetic Management
Standard intraoperative monitoring including BIS, pulse oximetry, temperature, and anesthesia workstation-derived respiratory variables. * Arterial blood gas sampling after intubation, before pneumoperitoneum, after pneumoperitoneum/positioning, hourly during pneumoperitoneum, at the end of pneumoperitoneum in supine position, and before extubation. * Routine safety limits on the anesthesia machine: end-tidal carbon dioxide upper alarm 45 mmHg, inspired oxygen lower alarm 35%, inspired carbon d
Primary outcome measures
- Arterial partial pressure of carbon dioxide (PaCO₂) [Time frame: intraoperative period, from post-intubation to before extubation on the day of surgery]
Secondary outcome measures (3)
- End-tidal carbon dioxide (EtCO₂) [Time frame: intraoperatively]
- Oxygenation parameters [Time frame: Intraoperative period (T0-Text).]
- Inhalational anesthetic consumption [Time frame: Postextubation]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07475533 · TABED1-26-2261