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

NCT02109133 | Completed Results

• 1 other identifier: 4-2014-0058
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Robot-Assisted Laparoscopic Radical Prostatectomy

Keywords

deep neuromuscular blockade; intraocular pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Overall Surgical Condition

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

Other Outcomes (2)

• Post-operative Nausea

  During 24hours after operation

• Incidence of Residual Neuromuscular Blockade

  During 24hours after operation

Study Arms (2)

Deep neuromuscular blockade

EXPERIMENTAL

Deep neuromuscular blockade

Procedure: deep neuromuscular blockade; Drug: Rocuronium; Drug: Sugammadex

moderate neuromuscular blockade

ACTIVE COMPARATOR

moderate neuromuscular blockade

Procedure: moderate neuromuscular blockade; Drug: Atracurium; Drug: Neostigmine

Interventions

deep neuromuscular blockade PROCEDURE

deep neuromuscular blockade using rocuronium and reverse with sugammadex

Deep neuromuscular blockade

moderate neuromuscular blockade PROCEDURE

moderate neuromuscular blockade using atracurium and reverse with neostigmine

moderate neuromuscular blockade

Rocuronium DRUG

Deep neuromuscular blockade

Sugammadex DRUG

Deep neuromuscular blockade

Atracurium DRUG

moderate neuromuscular blockade

Neostigmine DRUG

moderate neuromuscular blockade

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA class I-II
• obtaining written informed consent from the parents
• aged over 50 years who were undergoing robot- assisted laparoscopic prostatectomy

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, Seoul, 120-752, South Korea

Location

Related Publications (1)

• 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.

  PMID: 26317357 DERIVED

MeSH Terms

Interventions

Rocuronium; Sugammadex; Atracurium; Neostigmine

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Benzylisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Results Point of Contact

• Title: Dr. Sun-Jun, Bae
• Organization: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine,Severance Hospital, Yonsei University Health System

SJBAI1@yuhs.ac

+82-02-2228-4438

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2014
• First Posted: April 9, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 24, 2015
• Results First Posted: June 24, 2015

Record last verified: 2015-06

Locations

KR (1)