CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 102 enrolled
Drug / intervention
Sugammadex +3 moredrug
Likely dose
Not stated in 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/NCT02451202
NCT02451202Phase 4Completed

A Comparison of Surgical Conditions Between Deep vs Moderate Neuromuscular Blockade With Rocuronium in Patients Undergoing Endolaryngeal Procedures.

Chulalongkorn University·interventional·Posted May 21, 2015·Updated Jan 7, 2020

In Brief

A Phase 4 clinical trial evaluating Deep Neuromuscular Blockade, Moderate Neuromuscular Blockade, and 2 other interventions for Laryngoscopic Surgical Procedures. Completed, enrolled 102 participants.

Detailed Summary

It is unknown the impact of deep neuromuscular paralysis and using a novel agent, sugammadex as an reversal in endolaryngeal surgery. We will conduct a clinical study aiming to compare two treatment strategies; Deep neuromuscular Blockade and moderate Neuromuscular Blockade. We hypothesize that deep NMB will offer better stillness. We will also descriptively examine if patients would be safely discharged from a recovery room.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 21, 2015
Enrollment StartJun 1, 2016
Primary CompletionMar 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 11.1 years ago

Interventions

Deep Neuromuscular Blockadeprocedure

* During maintenance phase, if recovery after 1 Post-Tetanic-count (PTC) responses, a continuous infusion can be initiated to maintain deep NMB (TOF =0, PTC 1-2). * At the end of surgery, continuous infusion Rocuronium and Propofol are discontinued and paralysis will be simultaneously reversed by Sugammadex 4mg/kg from PTC 1-2.

Moderate Neuromuscular Blockadeprocedure

\- During maintenance phase, if recovery at the presence of \<10% of control T1 of TOF from initial doses of 0.6 mg rocuronium, a continuous infusion can be initiated to maintain TOF = 1 - 2. The initial pump rate will be set at 0.5 mg/kg per hour.

Sugammadexdrug

Rocuroniumdrug