N/A N=67 Randomized Double-blind Supportive Care

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

Robot-Assisted Laparoscopic Radical Prostatectomy

Bottom Line

View on ClinicalTrials.gov: NCT02109133 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2015

Primary outcome: Primary: Maximum Intraocular Pressure During RALRP Under Deep Neuromuscular Blockade — 23.3; 19.8 mmHg

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: deep neuromuscular blockade (Procedure); moderate neuromuscular blockade (Procedure); Rocuronium (Drug); Sugammadex (Drug); Atracurium (Drug); Neostigmine (Drug)
Age: Adult, Older Adult · 50+ yrs
Sex: Male
Sponsor: Yonsei University
Primary completion: Dec 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Maximum Intraocular Pressure During RALRP Under Deep Neuromuscular Blockade	23.3; 19.8	—
SECONDARY Overall Surgical Condition	4.0; 3.0	—

Summary

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.

Eligibility Criteria

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 30kg/m2

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02109133). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.