CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 108 enrolled
Drug / intervention
Rocuronium +1 moredrug
Likely dose
Sugammadex 2 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03039543
NCT03039543Phase 4Completed

The Effect of Neuromuscular Blockade During Transurethral Resection of Bladder Cancer on Surgical Condition and Recovery Profiles : A Prospective, Randomized and Controlled Trial

Seoul National University Bundang Hospital·interventional·Posted Feb 1, 2017·Updated May 22, 2018

In Brief

A Phase 4 clinical trial evaluating Rocuronium and Sugammadex for Neuromuscular Blockade. Completed, enrolled 108 participants across 1 site.

Detailed Summary

Transurethral resection of the bladder tumor (TURB) for bladder tumor excision is the mainstream treatment. However, the beneficial effects of sugammadex after general anesthesia for TURB have not been thoroughly evaluated. Investigators hypothesized that deep NMB and the use of sugammadex as a reversal agent may be associated with better endoscopic surgical condition and recovery profile compared with moderate NMB during TURB. This study was designed to compare patients with deep neuromuscular blockade (NMB) with moderate NMB during transurethral resection of the bladder tumor (TURB) in terms of surgical condition and postoperative recovery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSouth Korea
CollaboratorsMSD Korea Ltd.

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 1, 2017
Enrollment StartJun 1, 2017
Primary CompletionNov 10, 2017
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 9.4 years ago

Interventions

Rocuroniumdrug

Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.

Sugammadexdrug

Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2.