Sugammadex dose-finding study for reversal of deep rocuronium-induced neuromuscular block

Phase 1

• Conditions: decurarisation; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2019-000709-55-BE
• Lead Sponsor: niversitair Ziekenhuis Brussel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-13
• Last Update Posted: 12 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

- Patients scheduled to undergo elective maxillofacial surgical procedures with an expected duration of general anaesthesia of more than one hour
- 18–65 years
- body mass index 18.5–25.0 kg/m²
- ASA I–II
- general anesthesia with naso- or orotracheal intubation requiring only deep neuromusculair block (NMB) for the intubation procedure.
- Male-to-female allocation ratio 1:1 was respected at patient selection.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- suspected difficult airway
- bronchial asthma
- chronic obstructive pulmonary disease
- neuromuscular disease
- suspected malignant hyperthermia
- significant hepatic or renal dysfunction
- glaucoma
- allergy to the drugs used in this trial, and taking medication known to influence the effect of NMBAs.
- Patients who participated in another study in =1 month will not be included
- pregnant or breastfeeding patients.
The following medications are known to interact with NMB (neuromuscular blocker):
-Tetracyclines, aminoglycosides, polymyxins, and clindamycin potentiate neuromuscular blockade through inhibition of acetylcholine (ACh) release or desensitization of postjunctional nAChRs to ACh
-Patients receiving chronic treatment of anti-epileptic drugs are relatively resistant to nondepolarizing NMBAs due to accelerated clearance of these drugs
-Patients who take lithium can have a prolonged response to both depolarizing and nondepolarizing NMBAs
-In laboratory studies, sertraline and amitriptyline inhibit butyrylcholinesterase
-Local anesthetics (LAs) may enhance the effects of both depolarizing and nondepolarizing NMBAs through pre- and post-synaptic interactions at the neuromuscular junction (NMJ) Data on the effects of lidocaine on neuromuscular block are conflicting. Whereas one study reported that epidural lidocaine potentiated vecuronium-induced neuromuscular block , several studies have reported no effect of intravenous (IV) lidocaine on the onset, duration, or recovery from rocuronium-induced neuromuscular block ,

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified