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Clinical trial

Reversal of Neuromuscular Blockade During the General Anaesthesia

ID
Name
R19095M
Description
There are individual reports indicating that after the reversal of nondepolarizing neuromuscular blockade with neostigmine, some patients starts to relax spontaneously again after the tof ratio has already recovered to the safe level (\>90%). The mechanism behind this in not well understood, and the incidence of the phenomenon is unclear. In this study the investigators try to determine the incidence of the aforementioned postrecovery relaxation.
Trial arms
Trial start
2020-04-08
Estimated PCD
2025-12-31
Trial end
2025-12-31
Status
Recruiting
Treatment
Neostigmine, Combinations
All patients have neostigmine induced recovery of neuromuscular block.
Arms:
Study group
Size
120
Primary endpoint
Incidence of postrecovery relaxation
30 minutes
Eligibility criteria
Inclusion Criteria: * Elective surgery requiring general anaesthesia * Surgery is assumed to last more than 45 minutes * Body mass index less than 35kg/ m² Exclusion Criteria: * Disease of central nervous system * Trauma of central nervous system * Disease affecting peripheral nervous system * Medication affecting peripheral nervous system
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single group with same study protocol to asses the incidence of postrecovery relaxation', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}
Updated at
2024-04-17

1 organization

1 product

1 indication

Organization
Tampere University Hospital
Product
Neostigmine
Indication
Neuromuscular Blockade