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

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 Overview

• Status: Completed
• Conditions: Robot-Assisted Laparoscopic Radical Prostatectomy
• Intervention / Treatment: Drug: Rocuronium; Drug: Neostigmine; Drug: Sugammadex; Procedure: deep neuromuscular blockade; Procedure: moderate neuromuscular blockade; Drug: Atracurium

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Time Frame
Post-operative Nausea	During 24hours after operation
Incidence of Residual Neuromuscular Blockade	During 24hours after operation

Collaborators and Investigators

• Sponsor: Yonsei University

Publications and helpful links

General Publications

• Yoo YC, Kim NY, Shin S, Choi YD, Hong JH, Kim CY, Park H, Bai SJ. The Intraocular Pressure under Deep versus Moderate Neuromuscular Blockade during Low-Pressure Robot Assisted Laparoscopic Radical Prostatectomy in a Randomized Trial. PLoS One. 2015 Aug 28;10(8):e0135412. doi: 10.1371/journal.pone.0135412. eCollection 2015. Erratum In: PLoS One. 2018 Oct 18;13(10):e0206339.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: March 30, 2014
• First Submitted That Met QC Criteria: April 8, 2014
• First Posted (Estimate): April 9, 2014

Study Record Updates

• Last Update Posted (Estimate): June 24, 2015
• Last Update Submitted That Met QC Criteria: June 21, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: intraocular pressure; deep neuromuscular blockade
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Enzyme Inhibitors; Neuromuscular Agents; Cholinesterase Inhibitors; Nicotinic Antagonists; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Parasympathomimetics; Rocuronium; Neostigmine; Atracurium
• Other Study ID Numbers: 4-2014-0058