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Low-flow Versus Minimal-flow Sevoflurane Anesthesia During Robot-assisted Laparoscopic Radical Prostatectomy

NCT07475533 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-04-15

No results posted yet for this study

Summary

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

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 dioxide upper alarm 3 mmHg. * Routine device self-test each morning and between patients. * Minimal dead space strategy with avoidance of unnecessary circuit extension. * Close monitoring of soda lime; replacement if inspired carbon dioxide reaches 3 mmHg even without obvious color change. * If clinically necessary because of blood gas deterioration, BIS changes, or any safety concern, fresh gas flow may be increased and the participant may be withdrawn from the protocol intervention.

Sponsors & Collaborators

  • Ankara City Hospital Bilkent

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-20
Primary Completion
2026-04-20
Completion
2026-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07475533 on ClinicalTrials.gov