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Reversal of Neuromuscular Blockade During the General Anaesthesia

T

Tampere University Hospital

Status

Enrolling

Conditions

Neuromuscular Blockade

Treatments

Drug: Neostigmine, Combinations

Study type

Interventional

Funder types

Other

Identifiers

NCT04048655
R19095M

Details and patient eligibility

About

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.

Full description

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.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

120 participants in 1 patient group

Study group
Other group
Description:
Single arm and everyone gets the same treatment according the protocol
Treatment:
Drug: Neostigmine, Combinations

Trial contacts and locations

1

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Central trial contact

Maija Kalliomäki, Docent; Jarno Salminen, Licenciate

Data sourced from clinicaltrials.gov

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