Effects Of Anaesthesia on Intraocular Pressure in Robotic Prostate Surgery

NCT07033442 | Completed

• 1 other identifier: EthicsApproval: 152
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Robot Assisted Laparoscopic Radical prostatectomy; Intraoculer Pressure; Total Intravenous Anesthesia; Inhalation Anaesthesia

Outcome Measures

Primary Outcomes (1)

• 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.

  From 10 minutes before anesthesia induction to 45 minutes postoperatively

Secondary Outcomes (14)

• Heart Rate at Defined Perioperative Time Points (bpm)

  From 10 minutes before anesthesia induction to 45 minutes postoperatively.

• Bispectral Index Score (BIS) Values at Defined Perioperative Time Points

  From 10 minutes before anesthesia induction to 45 minutes postoperatively.

• Intraabdominal Pressure (IAP) at Defined Perioperative Time Points (mmHg)

  From CO₂ insufflation to desufflation during the intraoperative period.

• Peripheral Oxygen Saturation (SpO₂) at Defined Perioperative Time Points (%)

  From 10 minutes before anesthesia induction to 45 minutes postoperatively.

• End-Tidal Carbon Dioxide (ETCO₂) Levels at Defined Perioperative Time Points (mmHg)

  From 10 minutes before anesthesia induction to 45 minutes postoperatively.

Study Arms (2)

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

ACTIVE COMPARATOR

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

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

ACTIVE COMPARATOR

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

Interventions

Sevoflurane (Volatile Anesthetic) DRUG

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.

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

Propofol 1% DRUG

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.

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

Remifentanil 2 MG DRUG

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).

This group received general anesthesia maintained with a total intravenous technique.; This group received general anesthesia maintained with an inhalation-based technique.

Rocuronium 50 mg/5 ml DRUG

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.

This group received general anesthesia maintained with a total intravenous technique.; This group received general anesthesia maintained with an inhalation-based technique.

Lidocaine %2 ampoule DRUG

Administered intravenously at 1-1.5 mg/kg before anesthesia induction to reduce injection pain and facilitate induction.

This group received general anesthesia maintained with a total intravenous technique.; This group received general anesthesia maintained with an inhalation-based technique.

Thiopental 500 mg vial for injection DRUG

Intravenous anesthetic agent used for induction of anesthesia at 4-6 mg/kg.

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

Neostigmine 0,5 mg/ml ampoule DRUG

Administered IV at 0.04 mg/kg for reversal of neuromuscular blockade at the end of the procedure.

This group received general anesthesia maintained with a total intravenous technique.; This group received general anesthesia maintained with an inhalation-based technique.

Atropine Sulphate 0.5mg/ml ampoule DRUG

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).

This group received general anesthesia maintained with a total intravenous technique.; This group received general anesthesia maintained with an inhalation-based technique.

Ephedrine Hydrochloride 0,05 mg/ml ampoule DRUG

Used intravenously at 0.1 mg/kg to manage intraoperative hypotension unresponsive to fluid and anesthetic dose adjustment.

This group received general anesthesia maintained with a total intravenous technique.; This group received general anesthesia maintained with an inhalation-based technique.

CO₂ Pneumoperitoneum PROCEDURE

Creation of pneumoperitoneum with CO₂ insufflation for robotic prostatectomy; monitoring and recording of intra-abdominal pressures.

This group received general anesthesia maintained with a total intravenous technique.; This group received general anesthesia maintained with an inhalation-based technique.

Bispectral index (BIS) Monitoring DEVICE

Monitoring of depth of anesthesia using bispectral index values; frontal placement preoperatively and throughout surgery. BIS maintained between 40-60.

This group received general anesthesia maintained with a total intravenous technique.; This group received general anesthesia maintained with an inhalation-based technique.

intraocular pressure measurement PROCEDURE

Measurement of intraocular pressure (IOP) in both eyes at multiple intraoperative and postoperative time points (T0-T9).

This group received general anesthesia maintained with a total intravenous technique.; This group received general anesthesia maintained with an inhalation-based technique.

intraarterial cannulation and pressure measurement PROCEDURE

Invasive arterial blood pressure measurement and blood gas measurements via an 18G catheter inserted into the radial artery

This group received general anesthesia maintained with a total intravenous technique.; This group received general anesthesia maintained with an inhalation-based technique.

Mechanical Ventilation PROCEDURE

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.

This group received general anesthesia maintained with a total intravenous technique.; This group received general anesthesia maintained with an inhalation-based technique.

Peripheral Intravenous Cannulation PROCEDURE

All participants received peripheral intravenous cannulation using 18-20 G IV cannulas placed on the dorsum of the hand before anesthesia induction.

This group received general anesthesia maintained with a total intravenous technique.; This group received general anesthesia maintained with an inhalation-based technique.

Crystalloid solutions DRUG

Participants received calculated maintenance fluids with crystalloids through intravenous infusion prior to and during surgery.

This group received general anesthesia maintained with a total intravenous technique.; This group received general anesthesia maintained with an inhalation-based technique.

Endotracheal Intubation PROCEDURE

After induction of anesthesia and neuromuscular blockade, endotracheal intubation was performed using standard technique in all participants.

This group received general anesthesia maintained with a total intravenous technique.; This group received general anesthesia maintained with an inhalation-based technique.

American Society of Anesthesiologists (ASA) Standard Monitors PROCEDURE

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.

This group received general anesthesia maintained with a total intravenous technique.; This group received general anesthesia maintained with an inhalation-based technique.

Ventilatory Pressure and Compliance Monitoring PROCEDURE

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.

This group received general anesthesia maintained with a total intravenous technique.; This group received general anesthesia maintained with an inhalation-based technique.

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ataturk Training and Research Hospital: lead

MeSH Terms

Interventions

Sevoflurane; Propofol; Remifentanil; Rocuronium; Thiopental; Injections; Atropine; Intraocular Pressure; Respiration, Artificial; Crystalloid Solutions; Intubation, Intratracheal

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Thiobarbiturates; Barbiturates; Pyrimidinones; Pyrimidines; Drug Administration Routes; Drug Therapy; Therapeutics; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Ocular Physiological Phenomena; Airway Management; Resuscitation; Emergency Treatment; Respiratory Therapy; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Intubation; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: June 24, 2025
• Study Start: July 23, 2015
• Primary Completion: November 17, 2015
• Study Completion: December 24, 2015
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share