Effects Of Anaesthesia on Intraocular Pressure in Robotic Prostate Surgery

Not Applicable

Completed

• Conditions: Anaesthesia; Intraocular Pressure; Trendelenburg Position; Robot Assisted Laparoscopic Radical Prostatectomy; Total Intravenous Anesthesia; Inhalation Anesthesia
• Interventions: Drug: Propofol 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

• Registration Number: NCT07033442
• Lead Sponsor: Ataturk Training and Research Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2015-07-23
• Primary Completion: 2015-11-17
• Study Completion: 2015-12-24
• Study First Submitted: 2025-05-19
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-13
• Last Update Submitted: 2025-06-13
• Study First Posted: 2025-06-24
• Last Update Posted: 2025-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

• Patients who will undergo robot-assisted prostate surgery with ASA I-II

Exclusion Criteria

• serious cardiac disease
• restrictive and obstructive lung disease
• renal and hepatic insufficiency
• with a history of hypersensitivity to the agents to be used
• with psychiatric disorders
• with a history of neurological disease
• who had intracranial surgery
• with a history of alcohol, sedative, tranquilizer and long-term analgesic use,
• with glaucoma and those taking medications that would affect IOP
• who were thought to have difficult intubation during direct laryngoscopy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
This group received general anesthesia maintained with an inhalation-based technique.	Thiopental 500 mg vial for injection	Anesthesia was maintained in the patients using sevoflurane+remifentail infusion in Arm 1
This group received general anesthesia maintained with an inhalation-based technique.	Neostigmine 0,5 mg/ml ampoule	Anesthesia was maintained in the patients using sevoflurane+remifentail infusion in Arm 1
This group received general anesthesia maintained with an inhalation-based technique.	Atropine Sulphate 0.5mg/ml ampoule	Anesthesia was maintained in the patients using sevoflurane+remifentail infusion in Arm 1
This group received general anesthesia maintained with an inhalation-based technique.	Ephedrine Hydrochloride 0,05 mg/ml ampoule	Anesthesia was maintained in the patients using sevoflurane+remifentail infusion in Arm 1
This group received general anesthesia maintained with an inhalation-based technique.	CO₂ Pneumoperitoneum	Anesthesia was maintained in the patients using sevoflurane+remifentail infusion in Arm 1
This group received general anesthesia maintained with an inhalation-based technique.	Bispectral index (BIS) Monitoring	Anesthesia was maintained in the patients using sevoflurane+remifentail infusion in Arm 1
This group received general anesthesia maintained with an inhalation-based technique.	intraarterial cannulation and pressure measurement	Anesthesia was maintained in the patients using sevoflurane+remifentail infusion in Arm 1
This group received general anesthesia maintained with an inhalation-based technique.	intraocular pressure measurement	Anesthesia was maintained in the patients using sevoflurane+remifentail infusion in Arm 1
This group received general anesthesia maintained with an inhalation-based technique.	Crystalloid solutions	Anesthesia was maintained in the patients using sevoflurane+remifentail infusion in Arm 1
This group received general anesthesia maintained with an inhalation-based technique.	Mechanical Ventilation	Anesthesia was maintained in the patients using sevoflurane+remifentail infusion in Arm 1
This group received general anesthesia maintained with an inhalation-based technique.	Peripheral Intravenous Cannulation	Anesthesia was maintained in the patients using sevoflurane+remifentail infusion in Arm 1
This group received general anesthesia maintained with an inhalation-based technique.	Endotracheal Intubation	Anesthesia was maintained in the patients using sevoflurane+remifentail infusion in Arm 1
This group received general anesthesia maintained with a total intravenous technique.	CO₂ Pneumoperitoneum	Anesthesia was maintained in the patients using propofol+remifentanil infusion in Arm 2
This group received general anesthesia maintained with an inhalation-based technique.	American Society of Anesthesiologists (ASA) Standard Monitors	Anesthesia was maintained in the patients using sevoflurane+remifentail infusion in Arm 1
This group received general anesthesia maintained with a total intravenous technique.	Propofol 1%	Anesthesia was maintained in the patients using propofol+remifentanil infusion in Arm 2
This group received general anesthesia maintained with a total intravenous technique.	Remifentanil 2 MG	Anesthesia was maintained in the patients using propofol+remifentanil infusion in Arm 2
This group received general anesthesia maintained with an inhalation-based technique.	Ventilatory Pressure and Compliance Monitoring	Anesthesia was maintained in the patients using sevoflurane+remifentail infusion in Arm 1
This group received general anesthesia maintained with a total intravenous technique.	Rocuronium 50 mg/5 ml	Anesthesia was maintained in the patients using propofol+remifentanil infusion in Arm 2
This group received general anesthesia maintained with a total intravenous technique.	Lidocaine %2 ampoule	Anesthesia was maintained in the patients using propofol+remifentanil infusion in Arm 2
This group received general anesthesia maintained with a total intravenous technique.	Neostigmine 0,5 mg/ml ampoule	Anesthesia was maintained in the patients using propofol+remifentanil infusion in Arm 2
This group received general anesthesia maintained with a total intravenous technique.	Atropine Sulphate 0.5mg/ml ampoule	Anesthesia was maintained in the patients using propofol+remifentanil infusion in Arm 2
This group received general anesthesia maintained with a total intravenous technique.	Peripheral Intravenous Cannulation	Anesthesia was maintained in the patients using propofol+remifentanil infusion in Arm 2
This group received general anesthesia maintained with a total intravenous technique.	Crystalloid solutions	Anesthesia was maintained in the patients using propofol+remifentanil infusion in Arm 2
This group received general anesthesia maintained with a total intravenous technique.	Endotracheal Intubation	Anesthesia was maintained in the patients using propofol+remifentanil infusion in Arm 2
This group received general anesthesia maintained with a total intravenous technique.	American Society of Anesthesiologists (ASA) Standard Monitors	Anesthesia was maintained in the patients using propofol+remifentanil infusion in Arm 2
This group received general anesthesia maintained with a total intravenous technique.	Ventilatory Pressure and Compliance Monitoring	Anesthesia was maintained in the patients using propofol+remifentanil infusion in Arm 2
This group received general anesthesia maintained with a total intravenous technique.	Ephedrine Hydrochloride 0,05 mg/ml ampoule	Anesthesia was maintained in the patients using propofol+remifentanil infusion in Arm 2
This group received general anesthesia maintained with a total intravenous technique.	Bispectral index (BIS) Monitoring	Anesthesia was maintained in the patients using propofol+remifentanil infusion in Arm 2
This group received general anesthesia maintained with a total intravenous technique.	intraocular pressure measurement	Anesthesia was maintained in the patients using propofol+remifentanil infusion in Arm 2
This group received general anesthesia maintained with a total intravenous technique.	intraarterial cannulation and pressure measurement	Anesthesia was maintained in the patients using propofol+remifentanil infusion in Arm 2
This group received general anesthesia maintained with a total intravenous technique.	Mechanical Ventilation	Anesthesia was maintained in the patients using propofol+remifentanil infusion in Arm 2
This group received general anesthesia maintained with an inhalation-based technique.	Sevoflurane (Volatile Anesthetic)	Anesthesia was maintained in the patients using sevoflurane+remifentail infusion in Arm 1
This group received general anesthesia maintained with an inhalation-based technique.	Remifentanil 2 MG	Anesthesia was maintained in the patients using sevoflurane+remifentail infusion in Arm 1
This group received general anesthesia maintained with an inhalation-based technique.	Rocuronium 50 mg/5 ml	Anesthesia was maintained in the patients using sevoflurane+remifentail infusion in Arm 1
This group received general anesthesia maintained with an inhalation-based technique.	Lidocaine %2 ampoule	Anesthesia was maintained in the patients using sevoflurane+remifentail infusion in Arm 1

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.