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

NCT ID: NCT02451202

Last Updated: 2020-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2018-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Deep Neuromuscular Blockade

Intervention Type: 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.

Sugammadex

Intervention Type: DRUG

Rocuronium

Intervention Type: DRUG

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.

Group Type: ACTIVE_COMPARATOR

Moderate Neuromuscular Blockade

Intervention Type: 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.

Sugammadex

Intervention Type: DRUG

Rocuronium

Intervention Type: DRUG

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Sugammadex

Intervention Type: DRUG

Rocuronium

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Chulalongkorn University

OTHER

Sponsor Role: lead

Responsible Party

Oraluxna Rodanant

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Oraluxna Rodanant, MD

Role: PRINCIPAL_INVESTIGATOR

Anesthesiology Department, Faculty of Medicine, Culalongkorn University.

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

51815

Identifier Type: -

Identifier Source: org_study_id