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

Yonsei University67 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Robot-Assisted Laparoscopic Radical Prostatectomy

Interventions

deep neuromuscular blockadePROCEDURE

deep neuromuscular blockade using rocuronium and reverse with sugammadex

moderate neuromuscular blockadePROCEDURE

moderate neuromuscular blockade using atracurium and reverse with neostigmine

RocuroniumDRUG

Eligibility

Sex: MALEMin age: 50 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. ASA class I-II 2. obtaining written informed consent from the parents 3. aged over 50 years who were undergoing robot- assisted laparoscopic prostatectomy Exclusion Criteria: 1. eye surgery previously 2. unstable angina or congestive heart failure 3. concomitant eye disease (glaucoma, diabetic retinopathy, cataract, retinal detachment) 4. high intraocular pressure over 30mmHg after screening test. 5. uncontrolled hypertension (diastolic bp\>110mmHg) 6. coagulopathy 7. asthma 8. hepatic failure 9. renal failure(creatinine clearance \< 30 ml/min) 10. drug hyperactivity 11. neurological or psychiatric illnesses 12. mental retardation 13. patients who can't read the consent form due to illiterate or foreigner 14. previous malignant hyperthermia Hx 15. drug medication which interact with muscle relaxant (anti-convulsant, certain antibiotics, magnesium etc) 16. BMI \> 30kg/m2

Locations (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Seoul, Seoul, South Korea

Outcomes

Primary Outcomes

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

Time frame: Maximum intraocular pressure was measured at 60 minutes after CO2 pneumoperitoneum in the ST position

Secondary Outcomes

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.

Time frame: At the end of the Steep trendelenburg position, an average of 1 hour

Data from ClinicalTrials.gov

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