Reversal of Neuromuscular Blockade During the General Anaesthesia

September 9, 2025 updated by: Tampere University Hospital

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Tampere, Finland, 33520
        • Tampere University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of postrecovery relaxation
Time Frame: 30 minutes
Number of patients (if any) with postrecovery relaxation divided by a number of all patients
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tampere University Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2020

Primary Completion (Actual)

September 1, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

August 5, 2019

First Submitted That Met QC Criteria

August 6, 2019

First Posted (Actual)

August 7, 2019

Study Record Updates

Last Update Posted (Estimated)

September 16, 2025

Last Update Submitted That Met QC Criteria

September 9, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R19095M

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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