Effects Of Anaesthesia on Intraocular Pressure in Robotic Prostate Surgery

NCT07033442 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-06-24

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07033442 on ClinicalTrials.gov