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Deep Neuromuscular Blockade During Robotic Radical Prostatectomy

NCT02513693 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2015-08-03

No results posted yet for this study

Summary

Basic requirement for safe performance of the robotic intra-abdominal surgery is a calm and clear surgical field after the introduction of a capnoperitoneum. That can be enabled by a neuromuscular blockade. Provision of standard neuromuscular blockade is a compromise between optimal surgical conditions (sufficiently deep block) and capability to antagonize the block rapidly at the end of the surgery. With rocuronium, it is possible to maintain deep neuromuscular blockade safely until the very end of the surgery, and unlike with spontaneous recovery or reversal of the block with neostigmine, administration of sugammadex at the end of the surgery will enable quick and consistent reversal of the block. Project is focused on comparison of the parameters of deep and standard neuromuscular blockade - surgical conditions (primary endpoint), quality of recovery and turnover time (secondary endpoints).

Conditions

  • Neuromuscular Blockade

Interventions

DRUG

Standard neuromuscular blockade

Standard neuromuscular block provided by rocuronium to TOF-count 1-2. Reversal of the block with neostigmine.

DRUG

Deep neuromuscular blockade

Deep neuromuscular block provided by rocuronium to PTC 1-2. Reversal of the block with sugammadex.

Sponsors & Collaborators

  • University Hospital Olomouc

    collaborator OTHER

  • Masaryk Hospital Usti nad Labem

    collaborator OTHER

  • Palacky University

    lead OTHER

Principal Investigators

  • Milan Adamus, MD,PhD,MBA · Department of Anesthesiology and Intensive Care Medicine Palacky University Olomouc Faculty of Medicine and Dentistry

  • Vladimir Cerny, MD,PhD,FCCM · J. E. Purkinje University, Masaryk Hospital, Usti nad Labem, Czech Republic, Dept. of Anesthesiology, Perioperative Medicine and Intensive Care

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02513693 on ClinicalTrials.gov