Completed

NCT Number: NCT02451202

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.

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Key information

Conditions

Laryngoscopic Surgical Procedures

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Sugammadex

Drug

Rocuronium

Drug

Primary outcomes

Proportion of Patients Who Have a Clinically Acceptable Surgical Conditions

Time frame: intraoperative

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

Secondary outcomes

Time to Modified Aldrete's Score ≥ 9

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Collaborators

Merck Sharp & Dohme LLC

Registry information

Official study title

A Comparison of Surgical Conditions Between Deep vs Moderate Neuromuscular Blockade With Rocuronium in Patients Undergoing Endolaryngeal Procedures.

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: May 21, 2015
Registry last updated: Jan 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.