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?

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12617001505392

Enrollment

Registered

2017-10-25

Start date

2015-08-10

Completion date

2015-09-02

Last updated

2018-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

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,

Outcome results