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

• ClinicalTrials.gov Identifier: NCT02109133
• Recruitment Status: Completed
• First Posted: April 9, 2014
• Results First Posted: June 24, 2015
• Last Update Posted: June 24, 2015
• Sponsor: Yonsei University
• Information provided by (Responsible Party): Yonsei University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Robot-Assisted Laparoscopic Radical Prostatectomy	Procedure: deep neuromuscular blockade; Procedure: moderate neuromuscular blockade; Drug: Rocuronium; Drug: Sugammadex; Drug: Atracurium; Drug: Neostigmine	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 67 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Supportive Care
• Study Start Date: May 2014
• Actual Primary Completion Date: December 2014
• Actual Study Completion Date: December 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Maximum Intraocular Pressure During RALRP Under Deep Neuromuscular Blockade [ Time Frame: Maximum intraocular pressure was measured at 60 minutes after CO2 pneumoperitoneum in the ST position ]
   maximum intraocular pressure during RALRP under deep neuromuscular blockade after being positioned in the steep Trendelenburg position with CO2 pneumoperitoneum under deep neuromuscular blockade

Secondary Outcome Measures :

1. Overall Surgical Condition [ Time Frame: At the end of the Steep trendelenburg position, an average of 1 hour ]
   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.

Other Outcome Measures:

1. Post-operative Nausea [ Time Frame: During 24hours after operation ]
2. Incidence of Residual Neuromuscular Blockade [ Time Frame: During 24hours after operation ]

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Korea, Republic of

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

Seoul, Korea, Republic of, 120-752

Sponsors and Collaborators

Yonsei University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT02109133
• Other Study ID Numbers: 4-2014-0058
• First Posted: April 9, 2014
• Results First Posted: June 24, 2015
• Last Update Posted: June 24, 2015
• Last Verified: June 2015

Keywords provided by Yonsei University:

deep neuromuscular blockade; intraocular pressure

Additional relevant MeSH terms:

Rocuronium; Atracurium; Neostigmine; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Neuromuscular Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Cholinesterase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Neurotransmitter Agents; Parasympathomimetics; Autonomic Agents; Nicotinic Antagonists; Cholinergic Antagonists