Trial · NCT07033442
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Intraocular 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. |
| Secondary | Heart 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. |
| Secondary | Bispectral Index Score (BIS) Values at Defined Perioperative Time Points | From 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. |
| Secondary | Intraabdominal 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. |
| Secondary | Peripheral 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. |
| Secondary | End-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. |
| Secondary | Mean 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. |
| Secondary | Arterial 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. |
| Secondary | Arterial 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. |
| Secondary | Arterial Blood pH at Selected Perioperative Time Points | 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 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. |
| Secondary | Arterial Bicarbonate (HCO₃-) Level at Selected Perioperative Time Points (mEq/L) | 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 bicarbonate (HCO₃-) levels: 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 HCO₃- measurement will be reported separately. |
| Secondary | Peak Airway Pressure During Surgery (cmH₂O) | From T1 (10 minutes after anesthesia induction) to T8 (2 minutes after return to supine position). | Peak airway pressure will be monitored intraoperatively using the Mindray WATO EX-65 anesthesia machine. Measurements will be recorded throughout the surgical procedure (from anesthesia induction to end of anesthesia). 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) Each measurement will be reported separately. |
| Secondary | Positive End-Expiratory Pressure (PEEP) During Surgery (cmH₂O) | From T1 (10 minutes after anesthesia induction) to T8 (2 minutes after return to supine position). | Positive end-expiratory pressure (PEEP) will be monitored intraoperatively using the Mindray WATO EX-65 anesthesia machine. Measurements will be recorded throughout the surgical procedure (from anesthesia induction to end of anesthesia). 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) Each measurement will be reported separately. |
| Secondary | Plateau Pressure During Surgery (cmH₂O) | From T1 (10 minutes after anesthesia induction) to T8 (2 minutes after return to supine position). | Plateau pressure will be monitored intraoperatively using the Mindray WATO EX-65 anesthesia machine. Measurements will be recorded throughout the surgical procedure (from anesthesia induction to end of anesthesia). 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) Each measurement will be reported separately. |
| Secondary | Dynamic Pulmonary Compliance During Surgery (mL/cmH₂O) | From T1 (10 minutes after anesthesia induction) to T8 (2 minutes after return to supine position). | Dynamic pulmonary compliance will be monitored intraoperatively using the Mindray WATO EX-65 anesthesia machine. Measurements will be recorded throughout the surgical procedure. 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) Each measurement will be reported separately. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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