Electromyographic Activity of the Respiratory Muscles During Neostigmine or Sugammadex Enhanced Recovery After Neuromuscular Blockade

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

It was recently shown that neostigmine reversal was associated with increased atelectasis and that high-dose neostigmine was associated with longer postoperative length of stay and with an increased incidence of pulmonary edema and reintubation. These study results were consistent with findings from a previous epidemiological study which revealed an absence of beneficial effects of neostigmine on postoperative oxygenation and reintubation. In our previous study, the effects of neostigmine / glycopyrrolate and sugammadex on the electromyographic activity of the diaphragm showed beneficial effects for sugammadex. This could be explained by a possible effect on neuromuscular transmission at the muscle level, but can also be explained by a neostigmine-induced decrease in total nerve activity. In a study in cats, neostigmine has been shown to reduce efferent phrenic nerve activity. The investigators aim to show a difference in phrenic nerve activity between neostigmine and sugammadex, administered alone or in combination, in healthy male volunteers.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Onze Lieve Vrouw Hospital
• Treatments: Cholinesterase Inhibitors; Neostigmine; Rocuronium

Criteria

Inclusion Criteria:

• Only male, healthy volunteers will be enrolled after an in-depth interview.

• 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.

• Each participant must be between 18 and 40 years of age.

• Each participant must meet the American Society of Anaesthesiologists class I criteria.

Exclusion Criteria:

• The participant is known or suspected to have a neuromuscular disorder.

• The participant is known or suspected to have an allergic reaction to sugammadex, rocuronium, anaesthetic medications, or any drugs used during general anaesthesia.

• The participant is known or suspected to have an anatomical malformation impeding a proper intubation.

• The participant is known or suspected to have a history of malignant hyperthermia.

• The participant is known to have a renal insufficiency .

• The participant is known or suspected to have a chronic obstructive pulmonary disease GOLD classification 2 or higher.

• The participant is known to have an infection of the upper or lower airways, as diagnosed by clinical findings.