The Impacts of Surgical Visibility Through Deep Neuromuscular Blockade on Intraocular Pressure in Patients Undergoing Robot-Assisted Laparoscopic Radical Prostatectomy

Study Overview
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Brief Summary
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Intraocular pressure is significantly increase during robot-assisted laparoscopic radical prostatectomy which is performed in a steep trendelenburg position at prolonged times of pneumoperitoneum. Therefore investigators decided to evaluate the impacts of surgical visibility through deep neuromuscular blockade on intraocular pressure in patients undergoing Robot-Assisted Laparoscopic Radical Prostatectomy.

Conditions
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Robot-Assisted Laparoscopic Radical Prostatectomy

Intervention / Treatment
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* Procedure: deep neuromuscular blockade
* Procedure: moderate neuromuscular blockade
* Drug: Rocuronium
* Drug: Sugammadex
* Drug: Atracurium
* Drug: Neostigmine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA class I-II obtaining written informed consent from the parents aged over 50 years who were undergoing robot- assisted laparoscopic prostatectomy Exclusion Criteria: eye surgery previously unstable angina or congestive heart failure concomitant eye disease (glaucoma, diabetic retinopathy, cataract, retinal detachment) high intraocular pressure over 30mmHg after screening test. uncontrolled hypertension (diastolic bp>110mmHg) coagulopathy asthma hepatic failure renal failure(creatinine clearance < 30 ml/min) drug hyperactivity neurological or psychiatric illnesses mental retardation patients who can't read the consent form due to illiterate or foreigner previous malignant hyperthermia Hx drug medication which interact with muscle relaxant (anti-convulsant, certain antibiotics, magnesium etc) BMI > 30kg/m2

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deep neuromuscular blockade<br>Deep neuromuscular blockade | Procedure: deep neuromuscular blockade<br>* deep neuromuscular blockade using rocuronium and reverse with sugammadex<br>Drug: Rocuronium<br> <br> Drug: Sugammadex<br> <br> |
| Active Comparator: moderate neuromuscular blockade<br>moderate neuromuscular blockade | Procedure: moderate neuromuscular blockade<br>* moderate neuromuscular blockade using atracurium and reverse with neostigmine<br>Drug: Atracurium<br> <br> Drug: Neostigmine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Intraocular Pressure During RALRP Under Deep Neuromuscular Blockade | maximum intraocular pressure during RALRP under deep neuromuscular blockade after being positioned in the steep Trendelenburg position with CO2 pneumoperitoneum under deep neuromuscular blockade | Maximum intraocular pressure was measured at 60 minutes after CO2 pneumoperitoneum in the ST position | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Surgical Condition | overall surgical conditions using the 5-point rating scale as previously described: Grade 5 (optimal), optimal surgical conditions; grade 4 (good), nonoptimal conditions, but an intervention is not required; grade 3 (acceptable), wide surgical view, but an intervention can improve surgical conditions, grade 2 (poor), inadequate conditions, there is a visible view, but an intervention is necessary to ensure acceptable surgical conditions; grade 1 (extremely poor), inability to perform surgery; therefore, intervention is necessary. | At the end of the Steep trendelenburg position, an average of 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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deep neuromuscular blockade, intraocular pressure