Effects Of Anaesthesia on Intraocular Pressure in Robotic Prostate Surgery
NCT ID: NCT07033442
Last Updated: 2025-06-24
Study Results
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Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2015-07-23
2015-12-24
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
Study Groups
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This group received general anesthesia maintained with an inhalation-based technique.
Anesthesia was maintained in the patients using sevoflurane+remifentail infusion in Arm 1
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.
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).
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.
Lidocaine %2 ampoule
Administered intravenously at 1-1.5 mg/kg before anesthesia induction to reduce injection pain and facilitate induction.
Thiopental 500 mg vial for injection
Intravenous anesthetic agent used for induction of anesthesia at 4-6 mg/kg.
Neostigmine 0,5 mg/ml ampoule
Administered IV at 0.04 mg/kg for reversal of neuromuscular blockade at the end of the procedure.
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).
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.
CO₂ Pneumoperitoneum
Creation of pneumoperitoneum with CO₂ insufflation for robotic prostatectomy; monitoring and recording of intra-abdominal pressures.
Bispectral index (BIS) Monitoring
Monitoring of depth of anesthesia using bispectral index values; frontal placement preoperatively and throughout surgery. BIS maintained between 40-60.
intraocular pressure measurement
Measurement of intraocular pressure (IOP) in both eyes at multiple intraoperative and postoperative time points (T0-T9).
intraarterial cannulation and pressure measurement
Invasive arterial blood pressure measurement and blood gas measurements via an 18G catheter inserted into the radial artery
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.
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.
Crystalloid solutions
Participants received calculated maintenance fluids with crystalloids through intravenous infusion prior to and during surgery.
Endotracheal Intubation
After induction of anesthesia and neuromuscular blockade, endotracheal intubation was performed using standard technique in all participants.
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.
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.
This group received general anesthesia maintained with a total intravenous technique.
Anesthesia was maintained in the patients using propofol+remifentanil infusion in Arm 2
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.
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).
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.
Lidocaine %2 ampoule
Administered intravenously at 1-1.5 mg/kg before anesthesia induction to reduce injection pain and facilitate induction.
Neostigmine 0,5 mg/ml ampoule
Administered IV at 0.04 mg/kg for reversal of neuromuscular blockade at the end of the procedure.
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).
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.
CO₂ Pneumoperitoneum
Creation of pneumoperitoneum with CO₂ insufflation for robotic prostatectomy; monitoring and recording of intra-abdominal pressures.
Bispectral index (BIS) Monitoring
Monitoring of depth of anesthesia using bispectral index values; frontal placement preoperatively and throughout surgery. BIS maintained between 40-60.
intraocular pressure measurement
Measurement of intraocular pressure (IOP) in both eyes at multiple intraoperative and postoperative time points (T0-T9).
intraarterial cannulation and pressure measurement
Invasive arterial blood pressure measurement and blood gas measurements via an 18G catheter inserted into the radial artery
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.
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.
Crystalloid solutions
Participants received calculated maintenance fluids with crystalloids through intravenous infusion prior to and during surgery.
Endotracheal Intubation
After induction of anesthesia and neuromuscular blockade, endotracheal intubation was performed using standard technique in all participants.
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.
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.
Interventions
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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.
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.
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).
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.
Lidocaine %2 ampoule
Administered intravenously at 1-1.5 mg/kg before anesthesia induction to reduce injection pain and facilitate induction.
Thiopental 500 mg vial for injection
Intravenous anesthetic agent used for induction of anesthesia at 4-6 mg/kg.
Neostigmine 0,5 mg/ml ampoule
Administered IV at 0.04 mg/kg for reversal of neuromuscular blockade at the end of the procedure.
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).
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.
CO₂ Pneumoperitoneum
Creation of pneumoperitoneum with CO₂ insufflation for robotic prostatectomy; monitoring and recording of intra-abdominal pressures.
Bispectral index (BIS) Monitoring
Monitoring of depth of anesthesia using bispectral index values; frontal placement preoperatively and throughout surgery. BIS maintained between 40-60.
intraocular pressure measurement
Measurement of intraocular pressure (IOP) in both eyes at multiple intraoperative and postoperative time points (T0-T9).
intraarterial cannulation and pressure measurement
Invasive arterial blood pressure measurement and blood gas measurements via an 18G catheter inserted into the radial artery
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.
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.
Crystalloid solutions
Participants received calculated maintenance fluids with crystalloids through intravenous infusion prior to and during surgery.
Endotracheal Intubation
After induction of anesthesia and neuromuscular blockade, endotracheal intubation was performed using standard technique in all participants.
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.
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
MALE
No
Sponsors
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Ataturk Training and Research Hospital
OTHER
Responsible Party
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Aysun Erşen Yüngül
Principal Investigator
Other Identifiers
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EthicsApproval: 152
Identifier Type: -
Identifier Source: org_study_id
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