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

Chulalongkorn University

Status and phase: Completed; Phase 4

Conditions: Laryngoscopic Surgical Procedures

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02451202

51815

Details and patient eligibility

About

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.

Enrollment: 102 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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102 participants in 2 patient groups

Deep Neuromuscular Blockade arm

Experimental group

Description:

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).

Treatment:

Drug: Rocuronium

Drug: Sugammadex

Procedure: Deep Neuromuscular Blockade

Moderate Neuromuscular Blockade arm

Active Comparator group

Description:

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.

Treatment:

Procedure: Moderate Neuromuscular Blockade

Drug: Rocuronium

Drug: Sugammadex