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.

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 Overview

• Status: Completed
• Conditions: Laryngoscopic Surgical Procedures
• Intervention / Treatment: Drug: Rocuronium; Drug: Sugammadex; Procedure: Deep Neuromuscular Blockade; Procedure: Moderate Neuromuscular Blockade

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female aged 18 - 60 years; ASA I-III.
• Subjects have been planned for elective endolaryngeal. Procedures (Direct Laryngoscopy with laser (micro-)surgery in patients with Tis, T1, T2, supraglottis and glottis carcinoma)

Exclusion Criteria:

• Any renal impairment (CrCL < 80 ml/ min)
• Any hepatic impairment; Child Pugh A, B or C
• BMI > 30 kg m2
• Known or suspected generalized neuromuscular disorders
• Allergies to Rocuronium, Sugammadex, Sevoflurane, Propofol, fentanyl used during general anesthesia
• Hypersensitivity to the active substance or to any of the excipients
• Female patient who are pregnant and breastfeeding.
• Patient with poor Glasgow Coma Score and mental derangement who is unable to give informed consent.
• Patient with Tracheostomy tube.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Deep Neuromuscular Blockade arm; After initial doses of 0.6 mg Rocuronium, a continuous infusion can be initiated to maintain 0 responses to train-of-four (TOF) stimulation or 1-2 responses to Post-Tetanic Count (PTC) (Deep NMB). The pump rate will vary and depends on the PTC value. The initial pump rate will be set at 0.5 mg/kg per hour. In case of a deviation from the required PTC value the pump rate can be increased or decreased. This was left to the discretion of the attending anaesthetist. Deep NMB should be maintained throughout the operation. The infusion of Rocuronium will be discontinued and Sugammadex will be given 4 mg/kg at the end of surgery, which is from deep NMB (PTC = 1-2).	Drug: Rocuronium; Drug: Sugammadex; 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.
Active Comparator: Moderate Neuromuscular Blockade arm; After evidence of early spontaneous recovery (< 10% of control T1) from initial doses of 0.6 mg rocuronium, a continuous infusion can be initiated to maintain 1 to 2 responses to train-of-four stimulation (Moderate NMB). The initial pump rate will be set at 0.5 mg/kg per hour. In case of a deviation from the required TOF value the pump rate can be increased or decreased. This was left to the discretion of the attending anaesthesiologist. Moderate paralysis should be maintained throughout an operation. At the end of surgery, the infusion of Rocuronium will be discontinued and Sugammadex 2 mg/kg via bolus injections]will be administered at least reappearance of T2.	Drug: Rocuronium; Drug: Sugammadex; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Patients Who Have a Clinically Acceptable Surgical Conditions	Proportion of patients who have a excellent and good surgical condition score	intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Modified Aldrete's Score ≥ 9	Time from Post Anesthesia Care Unit (PACU) arrival to patients were considered fit for discharge from the PACU by Modified Aldrete's score assessment which scale range is from 0-10. Higher value represents a better outcome.	Minutes from Post Anesthesia Care Unit (PACU) arrival to patients were considered fit for discharge from the PACU.

Collaborators and Investigators

• Sponsor: Chulalongkorn University
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Oraluxna Rodanant, MD, Anesthesiology Department, Faculty of Medicine, Culalongkorn University.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: May 19, 2015
• First Submitted That Met QC Criteria: May 20, 2015
• First Posted (Estimate): May 21, 2015

Study Record Updates

• Last Update Posted (Actual): January 7, 2020
• Last Update Submitted That Met QC Criteria: December 18, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: "surgical conditions"; "deep neuromuscular blockade"; "deep neuromuscular paralysis"
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Rocuronium
• Other Study ID Numbers: 51815