Effects Of Anaesthesia on Intraocular Pressure in Robotic Prostate Surgery

Ataturk Training and Research Hospital

Status: Completed

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

Treatments: Procedure: Endotracheal Intubation; Procedure: intraocular pressure measurement; Procedure: CO₂ Pneumoperitoneum; Drug: Thiopental 500 mg vial for injection; Drug: Sevoflurane (Volatile Anesthetic); Procedure: Peripheral Intravenous Cannulation; Drug: Crystalloid solutions; Drug: Neostigmine 0,5 mg/ml ampoule; Procedure: American Society of Anesthesiologists (ASA) Standard Monitors; Drug: Propofol 1%; Drug: Remifentanil 2 MG; Drug: Atropine Sulphate 0.5mg/ml ampoule; Drug: Ephedrine Hydrochloride 0,05 mg/ml ampoule; Device: Bispectral index (BIS) Monitoring; Drug: Lidocaine %2 ampoule; Procedure: Mechanical Ventilation; Procedure: Ventilatory Pressure and Compliance Monitoring; Drug: Rocuronium 50 mg/5 ml; Procedure: intraarterial cannulation and pressure measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT07033442

EthicsApproval: 152

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Male

Volunteers: No Healthy Volunteers

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.

Trial design

60 participants in 2 patient groups

This group received general anesthesia maintained with an inhalation-based technique.

Active Comparator group

Description:

Anesthesia was maintained in the patients using sevoflurane+remifentail infusion in Arm 1

Treatment:

Procedure: Ventilatory Pressure and Compliance Monitoring

Procedure: intraarterial cannulation and pressure measurement

Drug: Rocuronium 50 mg/5 ml

Procedure: Mechanical Ventilation

Drug: Lidocaine %2 ampoule

Device: Bispectral index (BIS) Monitoring

Drug: Ephedrine Hydrochloride 0,05 mg/ml ampoule

Drug: Atropine Sulphate 0.5mg/ml ampoule

Drug: Remifentanil 2 MG

Procedure: American Society of Anesthesiologists (ASA) Standard Monitors

Drug: Neostigmine 0,5 mg/ml ampoule

Drug: Crystalloid solutions

Procedure: Peripheral Intravenous Cannulation

Drug: Thiopental 500 mg vial for injection

Drug: Sevoflurane (Volatile Anesthetic)

Procedure: CO₂ Pneumoperitoneum

Procedure: intraocular pressure measurement

Procedure: Endotracheal Intubation

This group received general anesthesia maintained with a total intravenous technique.

Active Comparator group

Description:

Anesthesia was maintained in the patients using propofol+remifentanil infusion in Arm 2

Treatment:

Procedure: Ventilatory Pressure and Compliance Monitoring

Procedure: intraarterial cannulation and pressure measurement

Drug: Rocuronium 50 mg/5 ml

Procedure: Mechanical Ventilation

Drug: Lidocaine %2 ampoule

Device: Bispectral index (BIS) Monitoring

Drug: Ephedrine Hydrochloride 0,05 mg/ml ampoule

Drug: Atropine Sulphate 0.5mg/ml ampoule

Drug: Remifentanil 2 MG

Drug: Propofol 1%

Procedure: American Society of Anesthesiologists (ASA) Standard Monitors

Drug: Neostigmine 0,5 mg/ml ampoule

Drug: Crystalloid solutions

Procedure: Peripheral Intravenous Cannulation

Procedure: CO₂ Pneumoperitoneum

Procedure: intraocular pressure measurement

Procedure: Endotracheal Intubation