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

Yonsei University

Status: Completed

Conditions: Robot-Assisted Laparoscopic Radical Prostatectomy

Treatments: Drug: Neostigmine; Drug: Sugammadex; Procedure: deep neuromuscular blockade; Procedure: moderate neuromuscular blockade; Drug: Rocuronium; Drug: Atracurium

Study type: Interventional

Funder types: Other

Identifiers

NCT02109133

4-2014-0058

Details and patient eligibility

About

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.

Enrollment: 67 patients

Sex: Male

Ages: 50 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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67 participants in 2 patient groups

Deep neuromuscular blockade

Experimental group

Description:

Deep neuromuscular blockade

Treatment:

Procedure: deep neuromuscular blockade

Drug: Sugammadex

Drug: Rocuronium

moderate neuromuscular blockade

Active Comparator group

Description:

moderate neuromuscular blockade

Treatment:

Drug: Neostigmine

Drug: Atracurium

Procedure: moderate neuromuscular blockade