CompletedPhase 4ACTRN12617001505392

Administration of clinical doses of neostigmine, commonly used in anaesthesia, and assessment of its effects on muscle strength, using a dynamometer, in healthy awake volunteers.

Do clinical doses of neostigmine induce muscle weakness, when administered to awake volunteers, in the absence of exposure to any non-depolarising neuromuscular blocking agents and if so does this have features of depolarising or non-depolarising blockade?


Sponsor

Australian Society of Anaesthetists

Enrollment

21 participants

Start Date

Aug 10, 2015

Study Type

Interventional

Conditions

Summary

Neostigmine is an anticholinesterase agent that is commonly used in anesthesia to reverse non-depolarizing neuromuscular blocking agents (NMBA). It is used to improve the rate of recovery from moderate non-depolarizing neuromuscular blockade and reduce the incidence of residual blockade. Neostigmine increases acetylcholine levels at the neuromuscular junction by inhibiting the breakdown of acetylcholine (Ach), which competitively antagonizes the NMBA. Neostigmine also acts at muscarinic sites leading to unwanted cholinergic side effects. Therefore the anti-muscarinic agents glycopyrrolate or atropine are administered in conjunction with neostigmine to reduce the severity of the effects. Clinical doses of neostigmine have been reported to cause muscle weakness when administered after full recovery from blockade. However, these reports are potentially confounded by the presence of other anesthetic agents also known to influence neuromuscular blockade.Without the use of quantitative neuromuscular function monitoring, patients who have spontaneously recovered from NMBAs may be given neostigmine unnecessarily. The primary aim of this study is to determine if clinical doses of neostigmine administered to healthy, unanesthetized volunteers would cause muscle weakness and impair respiratory function. We sought to define the size of the effect with hand grip strength, electromyography and spirometry. The secondary aim was to record the signs and symptoms experienced by the participants.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 60 Yearss

Inclusion Criteria1

  • We recruited healthy volunteers with American Society of Anesthesiologists (ASA) class I physical status to participate in the study.

Exclusion Criteria1

  • Pregnancy, history of neuromuscular or respiratory disease, or any condition that may interfere from the conduct of the study, such as allergy to the study medications or adhesive gel electrodes, currently taking any medication that may affect neuromuscular or respiratory function, or interfere with the study medications. ASA status equal to or greater than 2,

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Interventions

Neostigmine 2.5 mg and glycopyrrolate 450 micrograms administered intravenously to awake volunteers and this dose repeated again at 15 minutes from the time of the initial dose.

Neostigmine 2.5 mg and glycopyrrolate 450 micrograms administered intravenously to awake volunteers and this dose repeated again at 15 minutes from the time of the initial dose.


Locations(2)

Sydney Adventist Hospital - Wahroonga

NSW, Australia

Wollongong Hospital - Wollongong

NSW, Australia

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ACTRN12617001505392