Reversal of Neuromuscular Blockade During the General Anaesthesia

Sponsor

Tampere University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04048655

Collaborator

(none)

120

Enrollment

Location

Arm

32.8

Anticipated Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Neuromuscular Blockade	Drug: Neostigmine, Combinations	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Single group with same study protocol to asses the incidence of postrecovery relaxationSingle group with same study protocol to asses the incidence of postrecovery relaxation

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Reversal of Neuromuscular Blockade During the General Anaesthesia

Actual Study Start Date :

Apr 8, 2020

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Study group Single arm and everyone gets the same treatment according the protocol	Drug: Neostigmine, Combinations All patients have neostigmine induced recovery of neuromuscular block.

Arm

Intervention/Treatment

Other: Study group

Single arm and everyone gets the same treatment according the protocol

Drug: Neostigmine, Combinations

All patients have neostigmine induced recovery of neuromuscular block.

Outcome Measures

Primary Outcome Measures

Incidence of postrecovery relaxation [30 minutes]
Number of patients (if any) with postrecovery relaxation divided by a number of all patients

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tampere University Hospital	Tampere		Finland	33520

Sponsors and Collaborators

Tampere University Hospital

Investigators

Study Director: Maija Kalliomäki, Docent, Tampere University Hospital
Principal Investigator: Jarno Salminen, Licenciate, Tampere University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tampere University Hospital

ClinicalTrials.gov Identifier:

NCT04048655

Other Study ID Numbers:

R19095M

First Posted:

Aug 7, 2019

Last Update Posted:

Sep 28, 2021

Last Verified:

Aug 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Tampere University Hospital

neuromuscular blockade

Additional relevant MeSH terms:

Neostigmine

Study Results

No Results Posted as of Sep 28, 2021