Reversal of Neuromuscular Blockade During the General Anaesthesia

NCT ID: NCT04048655

Last Updated: 2025-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-08

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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There are individual reports indicating that after the reversal of nondepolarizing neuromuscular blockade with neostigmine, some patients start 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.

The aim of this study is to monitor the reversal of rocuronium induced neuromuscular blockade with neostigmine. The neuromuscular blockade is monitored with train of four stimulations using electromyography. After the reversal agent is given and train of four ratio has recovered to the level of 90%, the neuromuscular blockade is monitored another 30min to see if tof ratio starts to spontaneously fall again under the 90%. If aforementioned postrecovery relaxation happens, the investigators are able to calculate the incidence of the phenomenon.

Conditions

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Neuromuscular Blockade

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single group with same study protocol to asses the incidence of postrecovery relaxation
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Study group

Single arm and everyone gets the same treatment according the protocol

Group Type OTHER

Neostigmine, Combinations

Intervention Type DRUG

All patients have neostigmine induced recovery of neuromuscular block.

Interventions

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Neostigmine, Combinations

All patients have neostigmine induced recovery of neuromuscular block.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tampere University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maija Kalliomäki, Docent

Role: STUDY_DIRECTOR

Tampere University Hospital

Jarno Salminen, Licenciate

Role: PRINCIPAL_INVESTIGATOR

Tampere University Hospital

Locations

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Tampere University Hospital

Tampere, , Finland

Site Status

Countries

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Finland

Other Identifiers

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R19095M

Identifier Type: -

Identifier Source: org_study_id

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