Phase 4
N=102
Deep vs Moderate Neuromuscular Blockade With Rocuronium in Patients Undergoing Endolaryngeal Procedures
Laryngoscopic Surgical Procedures
Bottom Line
View on ClinicalTrials.gov: NCT02451202 ↗Enrolled (actual)
102
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Proportion of Patients Who Have a Clinically Acceptable Surgical Conditions — 0.89; 1 Proportion of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Deep Neuromuscular Blockade (Procedure); Moderate Neuromuscular Blockade (Procedure); Sugammadex (Drug); Rocuronium (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Chulalongkorn University
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients Who Have a Clinically Acceptable Surgical Conditions |
0.89; 1 | — |
| SECONDARY Time to Modified Aldrete's Score ≥ 9 |
27; 33 | — |
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.
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 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.
Data sourced from ClinicalTrials.gov (NCT02451202). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.