Prostate CancerNCT07475533
Low-flow Versus Minimal-flow Sevoflurane Anesthesia During Robot-assisted Laparoscopic Radical Prostatectomy
A study testing Common Anesthetic Management in people with Prostate Cancer and Anesthesia, run by Ankara City Hospital Bilkent.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer, Anesthesia, Respiratory Mechanics
- What is being tested?
- Common Anesthetic Management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2026to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
None listed.
About this study
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
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.
Read more
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
- Prostate Cancer, Anesthesia, Respiratory Mechanics
- Being tested
- Common Anesthetic Management
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Common Anesthetic ManagementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Common Anesthetic Management |
| 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. Receives: Other: Common Anesthetic Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial partial pressure of carbon dioxide (PaCO₂)
Comparison of arterial PaCO₂ 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).
Measured: intraoperative period, from post-intubation to before extubation on the day of surgery
Secondary outcomes (3)
End-tidal carbon dioxide (EtCO₂)
Comparison of end-tidal CO₂ levels between the minimal-flow and low-flow anesthesia groups during surgery.
Measured: intraoperatively
Oxygenation parameters
Peripheral oxygen saturation (SpO₂) and arterial oxygen partial pressure (PaO₂) measured to evaluate intraoperative oxygenation.
Measured: Intraoperative period (T0-Text).
Inhalational anesthetic consumption
Total sevoflurane consumption recorded from the anesthesia machine at the end of surgery.
Measured: Postextubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start20 Mar 2026 (estimated)
- Primary completion20 Apr 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betül Güven, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07475533
- Sponsor's protocol ID
- TABED1-26-2261
- Status last verified
- Apr 2026
- First submitted
- 8 Mar 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07475533
- Acronym / sponsor ID
- TABED1-26-2261
- Conditions
- Prostate Cancer, Anesthesia, Respiratory Mechanics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 20 Mar 2026 (estimated)
- Primary completion
- 20 Apr 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-flow sevoflurane arm | Experimental | Other: Common Anesthetic ManagementAfter 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 | Other: Common Anesthetic ManagementFresh gas flow 1 L/min after intubation until MAC 1 is achieved, then reduced to 0.5 L/min for maintenance anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Common Anesthetic ManagementStandard 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. | Other | Low-flow sevoflurane arm, Minimal-flow sevoflurane anesthesia |
Primary outcome
Arterial partial pressure of carbon dioxide (PaCO₂)
Time frame: intraoperative period, from post-intubation to before extubation on the day of surgery
Comparison of arterial PaCO₂ 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).
3 secondary outcomes
End-tidal carbon dioxide (EtCO₂)
Time frame: intraoperatively
Oxygenation parameters
Time frame: Intraoperative period (T0-Text).
Inhalational anesthetic consumption
Time frame: Postextubation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Common Anesthetic Management in people with Prostate Cancer and Anesthesia, run by Ankara City Hospital Bilkent.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial partial pressure of carbon dioxide (PaCO₂) (time frame: intraoperative period, from post-intubation to before extubation on the day of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.