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Not yet recruitingNCT07475533Updated Apr 15, 2026

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

An interventional study of Common Anesthetic Management in Prostate Cancer, Anesthesia and Respiratory Mechanics, sponsored by Ankara City Hospital Bilkent. Not yet recruiting. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-15.

Sponsored by Ankara City Hospital Bilkent · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Apr 2026, 5 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years and older
Sex
Male
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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.

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Conditions studied

  • Prostate Cancer
  • Anesthesia
  • Respiratory Mechanics

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In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's planned enrollment of 70 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Ankara City Hospital Bilkent is the lead sponsor of 424 studies on the registry; 105 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes

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.
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Low-flow sevoflurane arm

    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.

    Other: Common Anesthetic Management

  • Experimental
    Minimal-flow sevoflurane anesthesia

    Fresh gas flow 1 L/min after intubation until MAC 1 is achieved, then reduced to 0.5 L/min for maintenance anesthesia.

    Other: Common Anesthetic Management

Interventions

  • OtherCommon 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.

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What researchers measure

Primary outcomes

  1. 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).

    Time frame: intraoperative period, from post-intubation to before extubation on the day of surgery

Secondary outcomes

  1. End-tidal carbon dioxide (EtCO₂)

    Comparison of end-tidal CO₂ levels between the minimal-flow and low-flow anesthesia groups during surgery.

    Time frame: intraoperatively

  2. Oxygenation parameters

    Peripheral oxygen saturation (SpO₂) and arterial oxygen partial pressure (PaO₂) measured to evaluate intraoperative oxygenation.

    Time frame: Intraoperative period (T0-Text).

  3. Inhalational anesthetic consumption

    Total sevoflurane consumption recorded from the anesthesia machine at the end of surgery.

    Time frame: Postextubation

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07475533
Lead sponsor
Ankara City Hospital Bilkent
Responsible party
Betül Güven (Assos. Prof, Ankara City Hospital Bilkent) — Principal investigator
First posted
Mar 16, 2026
Start date
Mar 20, 2026 (estimated)
Primary completion
Apr 20, 2026 (estimated)
Completion
Aug 31, 2026 (estimated)
Last update
Apr 15, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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