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

Phase 4

Completed

• Conditions: Laryngoscopic Surgical Procedures
• Interventions: Procedure: Deep Neuromuscular Blockade; Procedure: Moderate Neuromuscular Blockade; Drug: Sugammadex; Drug: Rocuronium

• Registration Number: NCT02451202
• Lead Sponsor: Chulalongkorn University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-19
• Study First Submitted QC: 2015-05-20
• Study First Posted: 2015-05-21
• Study Start: 2016-06
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Results First Submitted: 2019-11-21
• Status Verified: 2019-12
• Results First Submitted QC: 2019-12-18
• Last Update Submitted: 2019-12-18
• Results First Posted: 2020-01-07
• Last Update Posted: 2020-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Deep Neuromuscular Blockade arm	Deep Neuromuscular Blockade	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).
Moderate Neuromuscular Blockade arm	Moderate Neuromuscular Blockade	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.
Deep Neuromuscular Blockade arm	Sugammadex	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).
Moderate Neuromuscular Blockade arm	Rocuronium	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.
Moderate Neuromuscular Blockade arm	Sugammadex	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.
Deep Neuromuscular Blockade arm	Rocuronium	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).

Primary Outcome Measures

Name	Time	Method
Proportion of Patients Who Have a Clinically Acceptable Surgical Conditions	intraoperative	Proportion of patients who have a excellent and good surgical condition score

Secondary Outcome Measures

Name	Time	Method
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.	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.