Recovery of diaphragmatic function after muscle relaxation with a muscle relaxant used in anaesthesia: sugammadex compared with neostigmine, two different drugs that counteract muscle paralysis. A study in healthy, anaesthetized volunteers.

• Conditions: We will compare usual care (neostigmine) with sugammadex for reversal of a moderate rocuronium-induced neuromuscular blockade and assess the effect on diaphragmatic EMG activity of sugammadex versus neostigmine.; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2013-002078-30-BE
• Lead Sponsor: Onze-Lieve-Vrouw Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-11
• Last Update Posted: 4 November 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

A subject is only eligible and may enter the study, if all of the following criteria are met:
1.Only male, healthy volunteers will be enrolled after an in-depth interview
2.Each participant must have the mental capacity to decide whether he takes part in the trial or not. Each participant must voluntarily give his written informed consent.
3.Each participant must be between 18 and 35 (inclusive) years of age at the screening visit
4.Each participant must meet the American Society of Anaesthesiologists class I criteria.
5.Subject has a Body Mass Index (BMI) = 26 kg/m2

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 12
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Volunteers may not have participated in a drug study within 90 days prior to dosing. A subject is ineligible and may not enter the study, if any of the following conditions are observed:
1.Known or suspected to have a neuromuscular disorder.
2.Use of medications known to interfere with NMBAs.
3.Known or suspected allergic reaction to sugammadex, neostigmine, rocuronium, anaesthetic or narcotic medications, or any drugs used during general anaesthesia.
4.Known or suspected to have an anatomical malformation impeding a proper intubation.
5.Family or personal history of problems related to anaesthesia.
6.Known or suspected to have a history of malignant hyperthermia.
7.Known to have a renal insufficiency.
8.Current smoker or history of smoking.
9.Drinking more than 2 consumptions of alcohol a day.
10.Known or suspected to have a chronic obstructive pulmonary disease GOLD classification 2 or higher.
11.Known to have an infection of the upper or lower airways, as diagnosed by clinical findings.
12.Reflux oesophagitis.

Study & Design

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