Effects Of Anaesthesia on Intraocular Pressure in Robotic Prostate Surgery
NCT07033442 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2025-06-24
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.
Conditions
- Anaesthesia
- Intraocular Pressure
- Trendelenburg Position
- Robot Assisted Laparoscopic Radical Prostatectomy
- Total Intravenous Anesthesia
- Inhalation Anesthesia
Interventions
- DRUG
-
Sevoflurane (Volatile Anesthetic)
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.
- DRUG
-
Propofol 1%
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.
- DRUG
-
Remifentanil 2 MG
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
-
Rocuronium 50 mg/5 ml
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.
- DRUG
-
Lidocaine %2 ampoule
Administered intravenously at 1-1.5 mg/kg before anesthesia induction to reduce injection pain and facilitate induction.
- DRUG
-
Thiopental 500 mg vial for injection
Intravenous anesthetic agent used for induction of anesthesia at 4-6 mg/kg.
- DRUG
-
Neostigmine 0,5 mg/ml ampoule
Administered IV at 0.04 mg/kg for reversal of neuromuscular blockade at the end of the procedure.
- DRUG
-
Atropine Sulphate 0.5mg/ml ampoule
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).
- DRUG
-
Ephedrine Hydrochloride 0,05 mg/ml ampoule
Used intravenously at 0.1 mg/kg to manage intraoperative hypotension unresponsive to fluid and anesthetic dose adjustment.
- PROCEDURE
-
CO₂ Pneumoperitoneum
Creation of pneumoperitoneum with CO₂ insufflation for robotic prostatectomy; monitoring and recording of intra-abdominal pressures.
- DEVICE
-
Bispectral index (BIS) Monitoring
Monitoring of depth of anesthesia using bispectral index values; frontal placement preoperatively and throughout surgery. BIS maintained between 40-60.
- PROCEDURE
-
intraocular pressure measurement
Measurement of intraocular pressure (IOP) in both eyes at multiple intraoperative and postoperative time points (T0-T9).
- PROCEDURE
-
intraarterial cannulation and pressure measurement
Invasive arterial blood pressure measurement and blood gas measurements via an 18G catheter inserted into the radial artery
- PROCEDURE
-
Mechanical Ventilation
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.
- PROCEDURE
-
Peripheral Intravenous Cannulation
All participants received peripheral intravenous cannulation using 18-20 G IV cannulas placed on the dorsum of the hand before anesthesia induction.
- DRUG
-
Crystalloid solutions
Participants received calculated maintenance fluids with crystalloids through intravenous infusion prior to and during surgery.
- PROCEDURE
-
Endotracheal Intubation
After induction of anesthesia and neuromuscular blockade, endotracheal intubation was performed using standard technique in all participants.
- PROCEDURE
-
American Society of Anesthesiologists (ASA) Standard Monitors
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.
- PROCEDURE
-
Ventilatory Pressure and Compliance Monitoring
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.
Sponsors & Collaborators
-
Ataturk Training and Research Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Model
- PARALLEL
Eligibility
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-07-23
- Primary Completion
- 2015-11-17
- Completion
- 2015-12-24
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