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

NCT02451202 | Completed Phase 4 Results

• 1 other identifier: 51815
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

"surgical conditions"; "deep neuromuscular blockade"; "deep neuromuscular paralysis"

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients Who Have a Clinically Acceptable Surgical Conditions

  Proportion of patients who have a excellent and good surgical condition score

  intraoperative

Secondary Outcomes (1)

• Time to Modified Aldrete's Score ≥ 9

  Minutes from Post Anesthesia Care Unit (PACU) arrival to patients were considered fit for discharge from the PACU.

Study Arms (2)

Deep Neuromuscular Blockade arm

EXPERIMENTAL

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).

Procedure: Deep Neuromuscular Blockade; Drug: Sugammadex; Drug: Rocuronium

Moderate Neuromuscular Blockade arm

ACTIVE COMPARATOR

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.

Procedure: Moderate Neuromuscular Blockade; Drug: Sugammadex; Drug: Rocuronium

Interventions

Deep Neuromuscular Blockade PROCEDURE

* 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.

Deep Neuromuscular Blockade arm

Moderate Neuromuscular Blockade PROCEDURE

\- 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.

Moderate Neuromuscular Blockade arm

Sugammadex DRUG

Deep Neuromuscular Blockade arm; Moderate Neuromuscular Blockade arm

Rocuronium DRUG

Deep Neuromuscular Blockade arm; Moderate Neuromuscular Blockade arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chulalongkorn University: lead
• Merck Sharp & Dohme LLC: collaborator

MeSH Terms

Interventions

Sugammadex; Rocuronium

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Androstanols; Androstanes; Steroids; Fused-Ring Compounds

Results Point of Contact

• Title: Dr. Prok Laosuwan
• Organization: Department of Anesthesiology, King Chulalongkorn Memorial Hospital

plaospir@yahoo.com

+66 2256 4295

Study Officials

• Oraluxna Rodanant, MD

  Anesthesiology Department, Faculty of Medicine, Culalongkorn University.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 19, 2015
• First Posted: May 21, 2015
• Study Start: June 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: January 7, 2020
• Results First Posted: January 7, 2020

Record last verified: 2019-12