Reversal of Neuromuscular Blockade During the General Anaesthesia

Neuromuscular Blockade Clinical Trial

Official title:

Reversal of Neuromuscular Blockade During the General Anaesthesia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04048655
• Other study ID #: R19095M
• Status: Recruiting
• Phase: N/A
• Start date: April 8, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Tampere University Hospital
• Contact: Jarno Salminen, Licenciate
• Phone: +358503480709
• Email: jarno.salminen[@]fimnet.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuromuscular Blockade

Intervention

Drug:
• Neostigmine, Combinations
All patients have neostigmine induced recovery of neuromuscular block.

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postrecovery relaxation	Number of patients (if any) with postrecovery relaxation divided by a number of all patients	30 minutes