NCT02451202

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Chulalongkorn University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2016-06-01
• Primary completion: 2018-03-01
• Completion: 2018-03-01
• First posted: 2015-05-21
• Last updated: 2020-01-07
• Results posted: 2020-01-07