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Trial · NCT07033442

Effects Of Anaesthesia on Intraocular Pressure in Robotic Prostate Surgery

NCT07033442, Not applicable, Completed, Ataturk Training and Research Hospital

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Effects Of Anaesthesia on Intraocular Pressure in Robotic Prostate Surgery. Trials, record NCT07033442. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07033442

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Effects Of Anaesthesia on Intraocular Pressure in Robotic Prostate Surgery
NCT number
NCT07033442
Status
Completed
Phases
Not applicable
Enrollment
60 participants, actual
Lead sponsor
Ataturk Training and Research Hospital
Conditions
Anaesthesia, Intraocular Pressure, Trendelenburg Position, Robot Assisted Laparoscopic Radical Prostatectomy, Total Intravenous Anesthesia, Inhalation Anesthesia
Interventions
Sevoflurane (Volatile Anesthetic), Propofol 1%, Remifentanil 2 MG, Rocuronium 50 mg/5 ml, Lidocaine %2 ampoule, Thiopental 500 mg vial for injection, Neostigmine 0,5 mg/ml ampoule, Atropine Sulphate 0.5mg/ml ampoule, Ephedrine Hydrochloride 0,05 mg/ml ampoule, CO₂ Pneumoperitoneum, Bispectral index (BIS) Monitoring, intraocular pressure measurement, intraarterial cannulation and pressure measurement, Mechanical Ventilation, Peripheral Intravenous Cannulation, Crystalloid solutions, Endotracheal Intubation, American Society of Anesthesiologists (ASA) Standard Monitors, Ventilatory Pressure and Compliance Monitoring
First posted
2025-06-24
Last updated
2025-06-24

Source ClinicalTrials.gov

Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryIntraocular Pressure Measured Using Tono-Pen at Multiple Perioperative Time Points (mmHg)From 10 minutes before anesthesia induction to 45 minutes postoperatively
Intraocular pressure (IOP) will be measured in both eyes using a handheld Tono-Pen tonometer at the following predefined perioperative time points: T0 (before anesthesia induction) T1 (10 minutes after induction) T2 (2 minutes after steep Trendelenburg positioning) T3 (2 minutes after carbon dioxide (CO₂) insufflation) T4 (1 hour after CO₂ insufflation) T5 (2 hours after CO₂ insufflation) T6 (3 hours after CO₂ insufflation) T7 (2 minutes after CO₂ desufflation) T8 (2 minutes after return to supine position) T9 (45 minutes postoperatively) The unit of measurement is mmHg at each time point. Each time point will be reported separately. To ensure consistency, all measurements will be performed by the same ophthalmologist.
SecondaryHeart Rate at Defined Perioperative Time Points (bpm)From 10 minutes before anesthesia induction to 45 minutes postoperatively.
Heart rate (HR) will be measured non-invasively using standard ASA monitoring equipment at the following perioperative time points: T0 (before anesthesia induction) T1 (10 minutes after induction) T2 (2 minutes after Trendelenburg positioning) T3 (2 minutes after carbon dioxide (CO₂) insufflation) T4 (1 hour after CO₂ insufflation) T5 (2 hours after CO₂ insufflation) T6 (3 hours after CO₂ insufflation) T7 (2 minutes after CO₂ desufflation) T8 (2 minutes after return to supine position) T9 (45 minutes postoperatively) Heart rate will be reported separately for each time point.
SecondaryBispectral Index Score (BIS) Values at Defined Perioperative Time PointsFrom 10 minutes before anesthesia induction to 45 minutes postoperatively.
The Bispectral Index Score (BIS) will be monitored to assess the depth of anesthesia. The BIS scale ranges from 0 (deep coma) to 100 (fully awake). Lower scores indicate deeper anesthesia, while higher scores indicate lighter anesthesia or awareness. Bispectral Index Score (BIS) values will be continuously monitored using the BIS VISTA Monitor (Covidien REF 185-0151). BIS values will be recorded at the following predefined perioperative time points to assess anesthetic depth: T0 (before anesthesia induction) T1 (10 minutes after induction) T2 (2 minutes after Trendelenburg positioning) T3 (2 minutes after carbon dioxide (CO₂) insufflation) T4 (1 hour after CO₂ insufflation) T5 (2 hours after CO₂ insufflation) T6 (3 hours after CO₂ insufflation) T7 (2 minutes after CO₂ desufflation) T8 (2 minutes after return to supine position) T9 (45 minutes postoperatively) Each BIS value will be reported separately for each time point.
SecondaryIntraabdominal Pressure (IAP) at Defined Perioperative Time Points (mmHg)From CO₂ insufflation to desufflation during the intraoperative period.
Intraabdominal pressure (IAP) will be monitored via the robotic insufflation system and recorded at the following predefined perioperative time points during carbon dioxide (CO₂) insufflation: T3 (2 minutes after CO₂ insufflation) T4 (1 hour after CO₂ insufflation) T5 (2 hours after CO₂ insufflation) T6 (3 hours after CO₂ insufflation) T7 (2 minutes after CO₂ desufflation) Each IAP measurement will be reported separately for each time point.
SecondaryPeripheral Oxygen Saturation (SpO₂) at Defined Perioperative Time Points (%)From 10 minutes before anesthesia induction to 45 minutes postoperatively.
Description: Peripheral oxygen saturation (SpO₂) will be continuously monitored using pulse oximetry as part of standard ASA monitoring. SpO₂ values will be documented at the following predefined perioperative time points to assess oxygenation: T0 (before anesthesia induction) T1 (10 minutes after induction) T2 (2 minutes after Trendelenburg positioning) T3 (2 minutes after carbon dioxide (CO₂) insufflation) T4 (1 hour after CO₂ insufflation) T5 (2 hours after CO₂ insufflation) T6 (3 hours after CO₂ insufflation) T7 (2 minutes after CO₂ desufflation) T8 (2 minutes after returning to supine position) T9 (45 minutes postoperatively) Each SpO₂ measurement will be reported separately for each time point.
SecondaryEnd-Tidal Carbon Dioxide (ETCO₂) Levels at Defined Perioperative Time Points (mmHg)From 10 minutes before anesthesia induction to 45 minutes postoperatively.
End-tidal carbon dioxide (ETCO₂) will be continuously measured through the ventilator (Mindray WATO EX-65) and documented at the following predefined perioperative time points: T0 (before anesthesia induction) T1 (10 minutes after induction) T2 (2 minutes after Trendelenburg positioning) T3 (2 minutes after carbon dioxide (CO₂) insufflation) T4 (1 hour after CO₂ insufflation) T5 (2 hours after CO₂ insufflation) T6 (3 hours after CO₂ insufflation) T7 (2 minutes after CO₂ desufflation) T8 (2 minutes after return to supine position) T9 (45 minutes postoperatively) Each ETCO₂ measurement will be reported separately for each time point.
SecondaryMean Arterial Pressure at Defined Perioperative Time Points (mmHg)From 10 minutes before anesthesia induction to 45 minutes postoperatively.
Mean arterial pressure (MAP) will be measured non-invasively using standard ASA monitoring equipment at the following perioperative time points: T0 (before anesthesia induction) T1 (10 minutes after induction) T2 (2 minutes after Trendelenburg positioning) T3 (2 minutes after carbon dioxide (CO₂) insufflation) T4 (1 hour after CO₂ insufflation) T5 (2 hours after CO₂ insufflation) T6 (3 hours after CO₂ insufflation) T7 (2 minutes after CO₂ desufflation) T8 (2 minutes after return to supine position) T9 (45 minutes postoperatively) Mean arterial pressure will be reported separately for each time point.
SecondaryArterial Partial Pressure of Oxygen (PaO₂) at Selected Perioperative Time Points (mmHg)From 10 minutes before anesthesia induction to 45 minutes postoperatively.
Arterial blood gas samples will be collected at the following perioperative time points to measure partial pressure of oxygen (PaO₂): T0 (before anesthesia induction) T1 (10 minutes after induction) T2 (2 minutes after Trendelenburg positioning) T3 (2 minutes after carbon dioxide (CO₂) insufflation) T4 (1 hour after CO₂ insufflation) T5 (2 hours after CO₂ insufflation) T6 (3 hours after CO₂ insufflation) T7 (2 minutes after CO₂ desufflation) T8 (2 minutes after return to supine position) T9 (45 minutes postoperatively) Each PaO₂ measurement will be reported separately.
SecondaryArterial Partial Pressure of Carbon Dioxide (PaCO₂) at Selected Perioperative Time Points (mmHg)From 10 minutes before anesthesia induction to 45 minutes postoperatively
Arterial blood gas samples will be collected at the following perioperative time points to measure partial pressure of carbon dioxide (PaCO₂): T0 (before anesthesia induction) T1 (10 minutes after induction) T2 (2 minutes after Trendelenburg positioning) T3 (2 minutes after carbon dioxide (CO₂) insufflation) T4 (1 hour after CO₂ insufflation) T5 (2 hours after CO₂ insufflation) T6 (3 hours after CO₂ insufflation) T7 (2 minutes after CO₂ desufflation) T8 (2 minutes after return to supine position) T9 (45 minutes postoperatively) Each PaCO₂ measurement will be reported separately.
SecondaryArterial Blood pH at Selected Perioperative Time PointsFrom 10 minutes before anesthesia induction to 45 minutes postoperatively.
Arterial blood gas samples will be collected at the following perioperative time points to measure blood pH: T0 (before anesthesia induction) T1 (10 minutes after induction) T2 (2 minutes after Trendelenburg positioning) T3 (2 minutes after carbon dioxide (CO₂) insufflation) T4 (1 hour after CO₂ insufflation) T5 (2 hours after CO₂ insufflation) T6 (3 hours after CO₂ insufflation) T7 (2 minutes after CO₂ desufflation) T8 (2 minutes after return to supine position) T9 (45 minutes postoperatively) Each pH measurement will be reported separately.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07033442

GET https://conductscience.org/api/trials/v1/NCT07033442/registered