AnaesthesiaNCT07033442
Effects Of Anaesthesia on Intraocular Pressure in Robotic Prostate Surgery
A study testing Sevoflurane (Volatile Anesthetic), Propofol 1% and Remifentanil 2 MG in people with Anaesthesia and Intraocular Pressure, run by Ataturk Training and Research Hospital.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Anaesthesia, Intraocular Pressure, Trendelenburg Position
- What is being tested?
- Sevoflurane (Volatile Anesthetic), Propofol 1% and Remifentanil 2 MG
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 23 Jul 2015to 24 Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who will undergo robot-assisted prostate surgery with ASA I-II
Who cannot join
- 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
Show all 10Show fewer
- 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.
About this study
Official title: Effects Of Inhalation Anaesthesia and Total Intravenous Anaesthesia on Intraocular Pressure in Robotic Prostate Surgery
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.
Read the detailed 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.
- Conditions
- Anaesthesia, Intraocular Pressure, Trendelenburg Position, Robot Assisted Laparoscopic Radical Prostatectomy, Total Intravenous Anesthesia, Inhalation Anesthesia
- Being tested
- Sevoflurane (Volatile Anesthetic), Propofol 1%, Remifentanil 2 MG, Rocuronium 50 mg/5 ml, Lidocaine %2 ampoule
- Keywords
- Robot Assisted Laparoscopic Radical prostatectomy, Intraoculer Pressure, Total Intravenous Anesthesia, Inhalation Anaesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
Remifentanil 2 MGDrug
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 mlDrug
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 ampouleDrug
Administered intravenously at 1-1.5 mg/kg before anesthesia induction to reduce injection pain and facilitate induction.
Thiopental 500 mg vial for injectionDrug
Intravenous anesthetic agent used for induction of anesthesia at 4-6 mg/kg.
Neostigmine 0,5 mg/ml ampouleDrug
Administered IV at 0.04 mg/kg for reversal of neuromuscular blockade at the end of the procedure.
Atropine Sulphate 0.5mg/ml ampouleDrug
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 ampouleDrug
Used intravenously at 0.1 mg/kg to manage intraoperative hypotension unresponsive to fluid and anesthetic dose adjustment.
CO₂ PneumoperitoneumProcedure or surgery
Creation of pneumoperitoneum with CO₂ insufflation for robotic prostatectomy; monitoring and recording of intra-abdominal pressures.
Bispectral index (BIS) MonitoringDevice
Monitoring of depth of anesthesia using bispectral index values; frontal placement preoperatively and throughout surgery. BIS maintained between 40-60.
intraocular pressure measurementProcedure or surgery
Measurement of intraocular pressure (IOP) in both eyes at multiple intraoperative and postoperative time points (T0-T9).
intraarterial cannulation and pressure measurementProcedure or surgery
Invasive arterial blood pressure measurement and blood gas measurements via an 18G catheter inserted into the radial artery
Mechanical VentilationProcedure or surgery
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 CannulationProcedure or surgery
All participants received peripheral intravenous cannulation using 18-20 G IV cannulas placed on the dorsum of the hand before anesthesia induction.
Crystalloid solutionsDrug
Participants received calculated maintenance fluids with crystalloids through intravenous infusion prior to and during surgery.
Endotracheal IntubationProcedure or surgery
After induction of anesthesia and neuromuscular blockade, endotracheal intubation was performed using standard technique in all participants.
American Society of Anesthesiologists (ASA) Standard MonitorsProcedure or surgery
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 MonitoringProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From 10 minutes before anesthesia induction to 45 minutes postoperatively
Secondary outcomes (14)
Heart Rate at Defined Perioperative Time Points (bpm)
Heart rate (HR) will be measured non-invasively using standard ASA monitoring equipment at the following perioperative time points:
T0 (before anesthesia induction) T1 (10 minutes after induction) T2 (2 minutes after 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)
Heart rate will be reported separately for each time point.
Measured: From 10 minutes before anesthesia induction to 45 minutes postoperatively.
Bispectral Index Score (BIS) Values at Defined Perioperative Time Points
The Bispectral Index Score (BIS) will be monitored to assess the depth of anesthesia. The BIS scale ranges from 0 (deep coma) to 100 (fully awake). Lower scores indicate deeper anesthesia, while higher scores indicate lighter anesthesia or awareness. Bispectral Index Score (BIS) values will be continuously monitored using the BIS VISTA Monitor (Covidien REF 185-0151). BIS values will be recorded at the following predefined perioperative time points to assess anesthetic depth:
T0 (before anesthesia induction) T1 (10 minutes after induction) T2 (2 minutes after 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) Each BIS value will be reported separately for each time point.
Measured: From 10 minutes before anesthesia induction to 45 minutes postoperatively.
Intraabdominal Pressure (IAP) at Defined Perioperative Time Points (mmHg)
Intraabdominal pressure (IAP) will be monitored via the robotic insufflation system and recorded at the following predefined perioperative time points during carbon dioxide (CO₂) insufflation:
T3 (2 minutes after 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)
Each IAP measurement will be reported separately for each time point.
Measured: From CO₂ insufflation to desufflation during the intraoperative period.
Peripheral Oxygen Saturation (SpO₂) at Defined Perioperative Time Points (%)
Description:
Peripheral oxygen saturation (SpO₂) will be continuously monitored using pulse oximetry as part of standard ASA monitoring.
SpO₂ values will be documented at the following predefined perioperative time points to assess oxygenation:
T0 (before anesthesia induction) T1 (10 minutes after induction) T2 (2 minutes after 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 returning to supine position) T9 (45 minutes postoperatively)
Each SpO₂ measurement will be reported separately for each time point.
Measured: From 10 minutes before anesthesia induction to 45 minutes postoperatively.
End-Tidal Carbon Dioxide (ETCO₂) Levels at Defined Perioperative Time Points (mmHg)
End-tidal carbon dioxide (ETCO₂) will be continuously measured through the ventilator (Mindray WATO EX-65) and documented at the following predefined perioperative time points:
T0 (before anesthesia induction) T1 (10 minutes after induction) T2 (2 minutes after 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)
Each ETCO₂ measurement will be reported separately for each time point.
Measured: From 10 minutes before anesthesia induction to 45 minutes postoperatively.
Mean Arterial Pressure at Defined Perioperative Time Points (mmHg)
Mean arterial pressure (MAP) will be measured non-invasively using standard ASA monitoring equipment at the following perioperative time points:
T0 (before anesthesia induction) T1 (10 minutes after induction) T2 (2 minutes after 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)
Mean arterial pressure will be reported separately for each time point.
Measured: From 10 minutes before anesthesia induction to 45 minutes postoperatively.
Arterial Partial Pressure of Oxygen (PaO₂) at Selected Perioperative Time Points (mmHg)
Arterial blood gas samples will be collected at the following perioperative time points to measure partial pressure of oxygen (PaO₂):
T0 (before anesthesia induction) T1 (10 minutes after induction) T2 (2 minutes after 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)
Each PaO₂ measurement will be reported separately.
Measured: From 10 minutes before anesthesia induction to 45 minutes postoperatively.
Arterial Partial Pressure of Carbon Dioxide (PaCO₂) at Selected Perioperative Time Points (mmHg)
Arterial blood gas samples will be collected at the following perioperative time points to measure partial pressure of carbon dioxide (PaCO₂):
T0 (before anesthesia induction) T1 (10 minutes after induction) T2 (2 minutes after 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)
Each PaCO₂ measurement will be reported separately.
Measured: From 10 minutes before anesthesia induction to 45 minutes postoperatively
Arterial Blood pH at Selected Perioperative Time Points
Arterial blood gas samples will be collected at the following perioperative time points to measure blood pH:
T0 (before anesthesia induction) T1 (10 minutes after induction) T2 (2 minutes after 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) Each pH measurement will be reported separately.
Measured: From 10 minutes before anesthesia induction to 45 minutes postoperatively.
Arterial Bicarbonate (HCO₃-) Level at Selected Perioperative Time Points (mEq/L)
Arterial blood gas samples will be collected at the following perioperative time points to measure bicarbonate (HCO₃-) levels:
T0 (before anesthesia induction) T1 (10 minutes after induction) T2 (2 minutes after 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)
Each HCO₃- measurement will be reported separately.
Measured: From 10 minutes before anesthesia induction to 45 minutes postoperatively.
Peak Airway Pressure During Surgery (cmH₂O)
Peak airway pressure will be monitored intraoperatively using the Mindray WATO EX-65 anesthesia machine. Measurements will be recorded throughout the surgical procedure (from anesthesia induction to end of anesthesia).
T1 (10 minutes after induction) T2 (2 minutes after 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)
Each measurement will be reported separately.
Measured: From T1 (10 minutes after anesthesia induction) to T8 (2 minutes after return to supine position).
Positive End-Expiratory Pressure (PEEP) During Surgery (cmH₂O)
Positive end-expiratory pressure (PEEP) will be monitored intraoperatively using the Mindray WATO EX-65 anesthesia machine. Measurements will be recorded throughout the surgical procedure (from anesthesia induction to end of anesthesia).
T1 (10 minutes after induction) T2 (2 minutes after 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)
Each measurement will be reported separately.
Measured: From T1 (10 minutes after anesthesia induction) to T8 (2 minutes after return to supine position).
Plateau Pressure During Surgery (cmH₂O)
Plateau pressure will be monitored intraoperatively using the Mindray WATO EX-65 anesthesia machine. Measurements will be recorded throughout the surgical procedure (from anesthesia induction to end of anesthesia).
T1 (10 minutes after induction) T2 (2 minutes after 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)
Each measurement will be reported separately.
Measured: From T1 (10 minutes after anesthesia induction) to T8 (2 minutes after return to supine position).
Dynamic Pulmonary Compliance During Surgery (mL/cmH₂O)
Dynamic pulmonary compliance will be monitored intraoperatively using the Mindray WATO EX-65 anesthesia machine. Measurements will be recorded throughout the surgical procedure.
T1 (10 minutes after induction) T2 (2 minutes after 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)
Each measurement will be reported separately.
Measured: From T1 (10 minutes after anesthesia induction) to T8 (2 minutes after return to supine position).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start23 Jul 2015
- Primary completion17 Nov 2015
- Study completion24 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnaesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysun Erşen Yüngül, Ataturk Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07033442
- Sponsor's protocol ID
- EthicsApproval: 152
- Status last verified
- Jun 2025
- First submitted
- 19 May 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Inhalation Anaesthesia and Total Intravenous Anaesthesia on Intraocular Pressure in Robotic Prostate Surgery
- ClinicalTrials.gov ID
- NCT07033442
- Acronym / sponsor ID
- EthicsApproval: 152
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ataturk Training and Research HospitalUniversity, hospital or other
- Study start
- 23 Jul 2015 (actual)
- Primary completion
- 17 Nov 2015 (actual)
- Study completion
- 24 Dec 2015 (actual)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| This group received general anesthesia maintained with an inhalation-based technique. | Active comparator | 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 MonitoringAnesthesia was maintained in the patients using sevoflurane+remifentail infusion in Arm 1 |
| This group received general anesthesia maintained with a total intravenous technique. | Active comparator | 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 MonitoringAnesthesia was maintained in the patients using propofol+remifentanil infusion in Arm 2 |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who will undergo robot-assisted prostate surgery with ASA I-II
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | This group received general anesthesia maintained with an inhalation-based technique. |
| 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 | This group received general anesthesia maintained with a total intravenous technique. |
| Remifentanil 2 MGShort-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 | 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 mlNeuromuscular 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 | This group received general anesthesia maintained with a total intravenous technique., This group received general anesthesia maintained with an inhalation-based technique. |
| Lidocaine %2 ampouleAdministered intravenously at 1-1.5 mg/kg before anesthesia induction to reduce injection pain and facilitate induction. | Drug | 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 injectionIntravenous anesthetic agent used for induction of anesthesia at 4-6 mg/kg. | Drug | This group received general anesthesia maintained with an inhalation-based technique. |
| Neostigmine 0,5 mg/ml ampouleAdministered IV at 0.04 mg/kg for reversal of neuromuscular blockade at the end of the procedure. | Drug | 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 ampouleAdministered 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 | 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 ampouleUsed intravenously at 0.1 mg/kg to manage intraoperative hypotension unresponsive to fluid and anesthetic dose adjustment. | Drug | This group received general anesthesia maintained with a total intravenous technique., This group received general anesthesia maintained with an inhalation-based technique. |
| CO₂ PneumoperitoneumCreation of pneumoperitoneum with CO₂ insufflation for robotic prostatectomy; monitoring and recording of intra-abdominal pressures. | Procedure or surgery | 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) MonitoringMonitoring of depth of anesthesia using bispectral index values; frontal placement preoperatively and throughout surgery. BIS maintained between 40-60. | Device | This group received general anesthesia maintained with a total intravenous technique., This group received general anesthesia maintained with an inhalation-based technique. |
| intraocular pressure measurementMeasurement of intraocular pressure (IOP) in both eyes at multiple intraoperative and postoperative time points (T0-T9). | Procedure or surgery | 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 measurementInvasive arterial blood pressure measurement and blood gas measurements via an 18G catheter inserted into the radial artery | Procedure or surgery | This group received general anesthesia maintained with a total intravenous technique., This group received general anesthesia maintained with an inhalation-based technique. |
| Mechanical VentilationVentilation 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 or surgery | This group received general anesthesia maintained with a total intravenous technique., This group received general anesthesia maintained with an inhalation-based technique. |
| Peripheral Intravenous CannulationAll participants received peripheral intravenous cannulation using 18-20 G IV cannulas placed on the dorsum of the hand before anesthesia induction. | Procedure or surgery | This group received general anesthesia maintained with a total intravenous technique., This group received general anesthesia maintained with an inhalation-based technique. |
| Crystalloid solutionsParticipants received calculated maintenance fluids with crystalloids through intravenous infusion prior to and during surgery. | Drug | This group received general anesthesia maintained with a total intravenous technique., This group received general anesthesia maintained with an inhalation-based technique. |
| Endotracheal IntubationAfter induction of anesthesia and neuromuscular blockade, endotracheal intubation was performed using standard technique in all participants. | Procedure or surgery | 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 MonitorsRoutine 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 or 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 MonitoringThroughout the procedure, the following lung mechanics were continuously measured: PEEP, peak airway pressure (PEAK), mean airway pressure (Pmean), plateau pressure (Pplato), and dynamic compliance. | Procedure or surgery | This group received general anesthesia maintained with a total intravenous technique., This group received general anesthesia maintained with an inhalation-based technique. |
Primary outcome
Intraocular Pressure Measured Using Tono-Pen at Multiple Perioperative Time Points (mmHg)
Time frame: From 10 minutes before anesthesia induction to 45 minutes postoperatively
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.
14 secondary outcomes
Heart Rate at Defined Perioperative Time Points (bpm)
Time frame: From 10 minutes before anesthesia induction to 45 minutes postoperatively.
Bispectral Index Score (BIS) Values at Defined Perioperative Time Points
Time frame: From 10 minutes before anesthesia induction to 45 minutes postoperatively.
Intraabdominal Pressure (IAP) at Defined Perioperative Time Points (mmHg)
Time frame: From CO₂ insufflation to desufflation during the intraoperative period.
Peripheral Oxygen Saturation (SpO₂) at Defined Perioperative Time Points (%)
Time frame: From 10 minutes before anesthesia induction to 45 minutes postoperatively.
End-Tidal Carbon Dioxide (ETCO₂) Levels at Defined Perioperative Time Points (mmHg)
Time frame: From 10 minutes before anesthesia induction to 45 minutes postoperatively.
Mean Arterial Pressure at Defined Perioperative Time Points (mmHg)
Time frame: From 10 minutes before anesthesia induction to 45 minutes postoperatively.
Arterial Partial Pressure of Oxygen (PaO₂) at Selected Perioperative Time Points (mmHg)
Time frame: From 10 minutes before anesthesia induction to 45 minutes postoperatively.
Arterial Partial Pressure of Carbon Dioxide (PaCO₂) at Selected Perioperative Time Points (mmHg)
Time frame: From 10 minutes before anesthesia induction to 45 minutes postoperatively
Arterial Blood pH at Selected Perioperative Time Points
Time frame: From 10 minutes before anesthesia induction to 45 minutes postoperatively.
Arterial Bicarbonate (HCO₃-) Level at Selected Perioperative Time Points (mEq/L)
Time frame: From 10 minutes before anesthesia induction to 45 minutes postoperatively.
Peak Airway Pressure During Surgery (cmH₂O)
Time frame: From T1 (10 minutes after anesthesia induction) to T8 (2 minutes after return to supine position).
Positive End-Expiratory Pressure (PEEP) During Surgery (cmH₂O)
Time frame: From T1 (10 minutes after anesthesia induction) to T8 (2 minutes after return to supine position).
Plateau Pressure During Surgery (cmH₂O)
Time frame: From T1 (10 minutes after anesthesia induction) to T8 (2 minutes after return to supine position).
Dynamic Pulmonary Compliance During Surgery (mL/cmH₂O)
Time frame: From T1 (10 minutes after anesthesia induction) to T8 (2 minutes after return to supine position).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Sevoflurane (Volatile Anesthetic), Propofol 1% and Remifentanil 2 MG in people with Anaesthesia and Intraocular Pressure, run by Ataturk Training and Research Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular Pressure Measured Using Tono-Pen at Multiple Perioperative Time Points (mmHg) (time frame: From 10 minutes before anesthesia induction to 45 minutes postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.