An interventional study of Sevoflurane (Volatile Anesthetic) and Propofol 1% in Anaesthesia, Intraocular Pressure and Trendelenburg Position, sponsored by Ataturk Training and Research Hospital. Completed. Open to male participants. Per ClinicalTrials.gov, last updated 2025-06-24.
Sponsored by Ataturk Training and Research Hospital · Not applicable, Interventional, and Other
Robot-assisted surgery is now commonly used to treat prostate cancer. This type of surgery, called robot-assisted prostatectomy, helps doctors operate more precisely and allows patients to heal faster. But there are some special things to be careful about during these surgeries.
During the operation, the patient is placed in a steep head-down position for a long time. Staying in this position for a long period can cause the pressure inside the eyes-called intraocular pressure (IOP)-to go up. High eye pressure can be risky, especially for people who already have eye problems.
This study looked at different types of anesthesia used during robotic prostate surgery to see how they affect eye pressure. The goal was to find out which type of anesthesia causes less of an increase in eye pressure.
In this study, the aim was to investigate the effects of hemodynamic changes induced by the steep Trendelenburg position and pneumoperitoneum, surgical duration, blood gas parameters, and the type of anesthesia administered on intraocular pressure (IOP) during robotic prostatectomy.
Prostate cancer is the most common type of cancer among men. Among the various treatment options, robot-assisted radical prostatectomy (RARP) stands out as the most recent and technologically advanced surgical approach.
This randomized and prospective study was conducted at the operating rooms of Ankara Atatürk Training and Research Hospital following approval by the Ethics Committee. Sixty cooperative adult male patients scheduled to undergo robotic prostatectomy under general anesthesia and classified as ASA physical status I-II were enrolled in the study after providing informed written consent.
Patients with severe cardiac disease, restrictive or obstructive pulmonary disease, renal or hepatic insufficiency, a history of hypersensitivity to anesthetic agents, psychiatric disorders, neurologic diseases, previous intracranial surgery, chronic alcohol, sedative, tranquilizer, or analgesic use, glaucoma, or those receiving medications known to affect IOP, as well as patients predicted to present with difficult intubation on direct laryngoscopy, were excluded from the study.
Participants were randomly assigned to one of two groups by drawing a label from a sealed envelope: Group 1 received inhalation anesthesia, and Group 2 received total intravenous anesthesia (TIVA). Demographic data were recorded. Prior to the induction of general anesthesia, while the participants were in the supine position, baseline measurements were taken, including heart rate (HR), mean arterial pressure (MAP), peripheral oxygen saturation (SpO₂), end-tidal CO₂ (ETCO₂), bispectral index (BIS), and IOP in both eyes.
Anesthesia induction was carried out using the following agents: patients in Group 1 received intravenous Lidocaine at a dose of 1-1.5 mg/kg, Thiopental 4-6 mg/kg, Remifentanil 1 µg/kg, and Rocuronium 0.6-1.2 mg/kg. In Group 2, Lidocaine 1-1.5 mg/kg, Propofol 2-3 mg/kg, Remifentanil 1 µg/kg, and Rocuronium 0.6-1.2 mg/kg were administered. For anesthesia maintenance, Group 1 was managed with Sevoflurane combined with a Remifentanil infusion, while Group 2 received a combination of Propofol and Remifentanil infusions.
Intraocular pressure (IOP), hemodynamic parameters, arterial blood gas values, pulmonary mechanics, heart rate (HR), mean arterial pressure (MAP), systolic and diastolic blood pressure, bispectral index (BIS), peripheral oxygen saturation (SpO₂), and end-tidal carbon dioxide (ETCO₂) levels were evaluated at ten specific time points throughout the procedure. These included: before anesthesia induction (T0); 10 minutes after induction (T1); 2 minutes after positioning the participant in the steep Trendelenburg position (T2); 2 minutes following carbon dioxide (CO₂) insufflation (T3); 1 hour (T4), 2 hours (T5), and 3 hours (T6) after CO₂ insufflation; 2 minutes after CO₂ desufflation (T7); 2 minutes after returning the participant to the supine position (T8); and 45 minutes postoperatively (T9).
Intra-abdominal pressures generated by CO₂ insufflation, as well as the minimum alveolar concentration (MAC) of sevoflurane and ETCO₂ values, were also recorded.
Ataturk Training and Research Hospital is the lead sponsor of 24 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anesthesia was maintained in the patients using sevoflurane+remifentail infusion in Arm 1
Drug: Sevoflurane (Volatile Anesthetic) · Drug: Remifentanil 2 MG · Drug: Rocuronium 50 mg/5 ml · Drug: Lidocaine %2 ampoule · Drug: Thiopental 500 mg vial for injection · Drug: Neostigmine 0,5 mg/ml ampoule · Drug: Atropine Sulphate 0.5mg/ml ampoule · Drug: Ephedrine Hydrochloride 0,05 mg/ml ampoule · Procedure: CO₂ Pneumoperitoneum · Device: Bispectral index (BIS) Monitoring · Procedure: intraocular pressure measurement · Procedure: intraarterial cannulation and pressure measurement · Procedure: Mechanical Ventilation · Procedure: Peripheral Intravenous Cannulation · Drug: Crystalloid solutions · Procedure: Endotracheal Intubation · Procedure: American Society of Anesthesiologists (ASA) Standard Monitors · Procedure: Ventilatory Pressure and Compliance Monitoring
Anesthesia was maintained in the patients using propofol+remifentanil infusion in Arm 2
Drug: Propofol 1% · Drug: Remifentanil 2 MG · Drug: Rocuronium 50 mg/5 ml · Drug: Lidocaine %2 ampoule · Drug: Neostigmine 0,5 mg/ml ampoule · Drug: Atropine Sulphate 0.5mg/ml ampoule · Drug: Ephedrine Hydrochloride 0,05 mg/ml ampoule · Procedure: CO₂ Pneumoperitoneum · Device: Bispectral index (BIS) Monitoring · Procedure: intraocular pressure measurement · Procedure: intraarterial cannulation and pressure measurement · Procedure: Mechanical Ventilation · Procedure: Peripheral Intravenous Cannulation · Drug: Crystalloid solutions · Procedure: Endotracheal Intubation · Procedure: American Society of Anesthesiologists (ASA) Standard Monitors · Procedure: Ventilatory Pressure and Compliance Monitoring
Inhalational anesthetic used for maintenance of anesthesia. Administered at 2-3% concentration in a 40% oxygen-air mixture to maintain BIS values between 40-60.
Intravenous hypnotic agent used for induction (2-3 mg/kg) and maintenance (50-150 μg/kg/min) of anesthesia. Titrated to maintain BIS values between 40-60.
Short-acting opioid used for induction and maintenance of anesthesia at a dose of 1 μg/kg IV (induction) and 0.05-0.25 μg/kg/min (maintenance).
Drug page: Rocuronium
Neuromuscular blocker administered IV at 0.6-1.2 mg/kg for induction and 0.15 mg/kg for maintenance of muscle relaxation during surgery.
Administered intravenously at 1-1.5 mg/kg before anesthesia induction to reduce injection pain and facilitate induction.
Intravenous anesthetic agent used for induction of anesthesia at 4-6 mg/kg.
Administered IV at 0.04 mg/kg for reversal of neuromuscular blockade at the end of the procedure.
Drug page: Atropine
Administered intravenously (0.4 mg per 1 mg neostigmine) to counteract muscarinic effects during neuromuscular blockade reversal; also 0.5 mg IV in cases of intraoperative bradycardia (HR \< 45 bpm).
Used intravenously at 0.1 mg/kg to manage intraoperative hypotension unresponsive to fluid and anesthetic dose adjustment.
Creation of pneumoperitoneum with CO₂ insufflation for robotic prostatectomy; monitoring and recording of intra-abdominal pressures.
Monitoring of depth of anesthesia using bispectral index values; frontal placement preoperatively and throughout surgery. BIS maintained between 40-60.
Measurement of intraocular pressure (IOP) in both eyes at multiple intraoperative and postoperative time points (T0-T9).
Invasive arterial blood pressure measurement and blood gas measurements via an 18G catheter inserted into the radial artery
Ventilation initiated after intubation with volume-controlled settings (TV 6-8 ml/kg, RR 12, FiO₂ 50%), adjusted to maintain ETCO₂ between 30-36 mmHg.
All participants received peripheral intravenous cannulation using 18-20 G IV cannulas placed on the dorsum of the hand before anesthesia induction.
Participants received calculated maintenance fluids with crystalloids through intravenous infusion prior to and during surgery.
After induction of anesthesia and neuromuscular blockade, endotracheal intubation was performed using standard technique in all participants.
Routine ASA monitoring, including noninvasive blood pressure, ECG (D2 derivation), End-tidal carbon dioxide (ETCO₂) and Peripheral Oxygen Saturation (SpO₂), was performed in all patients, starting from the preoperative period and continuing throughout the surgery.
Throughout the procedure, the following lung mechanics were continuously measured: PEEP, peak airway pressure (PEAK), mean airway pressure (Pmean), plateau pressure (Pplato), and dynamic compliance.
Intraocular Pressure Measured Using Tono-Pen at Multiple Perioperative Time Points (mmHg)
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.
Time frame: From 10 minutes before anesthesia induction to 45 minutes postoperatively
Heart Rate at Defined Perioperative Time Points (bpm)
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.
Time frame: From 10 minutes before anesthesia induction to 45 minutes postoperatively.
Bispectral Index Score (BIS) Values at Defined Perioperative Time Points
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.
Time frame: From 10 minutes before anesthesia induction to 45 minutes postoperatively.
Intraabdominal Pressure (IAP) at Defined Perioperative Time Points (mmHg)
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.
Time frame: From CO₂ insufflation to desufflation during the intraoperative period.
Peripheral Oxygen Saturation (SpO₂) at Defined Perioperative Time Points (%)
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.
Time frame: From 10 minutes before anesthesia induction to 45 minutes postoperatively.
End-Tidal Carbon Dioxide (ETCO₂) Levels at Defined Perioperative Time Points (mmHg)
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.
Time frame: From 10 minutes before anesthesia induction to 45 minutes postoperatively.
Mean Arterial Pressure at Defined Perioperative Time Points (mmHg)
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.
Time frame: From 10 minutes before anesthesia induction to 45 minutes postoperatively.
Arterial Partial Pressure of Oxygen (PaO₂) at Selected Perioperative Time Points (mmHg)
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.
Time frame: From 10 minutes before anesthesia induction to 45 minutes postoperatively.
Arterial Partial Pressure of Carbon Dioxide (PaCO₂) at Selected Perioperative Time Points (mmHg)
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.
Time frame: From 10 minutes before anesthesia induction to 45 minutes postoperatively
Arterial Blood pH at Selected Perioperative Time Points
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.
Time frame: From 10 minutes before anesthesia induction to 45 minutes postoperatively.
Arterial Bicarbonate (HCO₃-) Level at Selected Perioperative Time Points (mEq/L)
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.
Time frame: From 10 minutes before anesthesia induction to 45 minutes postoperatively.
Peak Airway Pressure During Surgery (cmH₂O)
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.
Time frame: From T1 (10 minutes after anesthesia induction) to T8 (2 minutes after return to supine position).
Positive End-Expiratory Pressure (PEEP) During Surgery (cmH₂O)
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.
Time frame: From T1 (10 minutes after anesthesia induction) to T8 (2 minutes after return to supine position).
Plateau Pressure During Surgery (cmH₂O)
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.
Time frame: From T1 (10 minutes after anesthesia induction) to T8 (2 minutes after return to supine position).
Dynamic Pulmonary Compliance During Surgery (mL/cmH₂O)
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.
Time frame: From T1 (10 minutes after anesthesia induction) to T8 (2 minutes after return to supine position).
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Plan to share: No
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Ran from Jul 2015 to primary completion in Nov 2015, 3 months.
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Studies of the drugs tested here: Sevoflurane · Propofol · Thiopental
Ataturk Training and Research Hospital