MedTrace Logo

Deep vs Moderate Neuromuscular Blockade With Rocuronium in Patients Undergoing Endolaryngeal Procedures

NCT02451202 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2020-01-07

Study results available
· View outcomes & findings →

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.

Conditions

  • Laryngoscopic Surgical Procedures

Interventions

PROCEDURE

Deep Neuromuscular Blockade

* 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.

PROCEDURE

Moderate Neuromuscular Blockade

\- 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.

DRUG

Sugammadex

DRUG

Rocuronium

Sponsors & Collaborators

Principal Investigators

  • Oraluxna Rodanant, MD · Anesthesiology Department, Faculty of Medicine, Culalongkorn University.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2018-03-31
Completion
2018-03-31

More Related Trials

Entities

Companies

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 NCT02451202 on ClinicalTrials.gov