Reversal of Neuromuscular Blockade During the General Anaesthesia

Not Applicable

Active, not recruiting

• Conditions: Neuromuscular Blockade
• Interventions: Drug: Neostigmine, Combinations

• Registration Number: NCT04048655
• Lead Sponsor: Tampere University Hospital

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.

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 Timeline

• Study First Submitted: 2019-08-05
• Study First Submitted QC: 2019-08-06
• Study First Posted: 2019-08-07
• Study Start: 2020-04-08
• Status Verified: 2025-09
• Primary Completion: 2025-09-01
• Last Update Submitted: 2025-09-09
• Last Update Posted: 2025-09-16
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study group	Neostigmine, Combinations	Single arm and everyone gets the same treatment according the protocol

Primary Outcome Measures

Name	Time	Method
Incidence of postrecovery relaxation	30 minutes	Number of patients (if any) with postrecovery relaxation divided by a number of all patients

Trial Locations

Locations (1)

Tampere University Hospital; 🇫🇮 Tampere, Finland