NCT04048655

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

April 8, 2020

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

September 16, 2025

Status Verified

September 1, 2025

Enrollment Period

5.4 years

First QC Date

August 5, 2019

Last Update Submit

September 9, 2025

Conditions

Neuromuscular Blockade

Keywords

neuromuscular blockadeneostigminemuscle relaxationtrain of fourrocuronium

Outcome Measures

Primary Outcomes (1)

  • Incidence of postrecovery relaxation

    Number of patients (if any) with postrecovery relaxation divided by a number of all patients

    30 minutes

Study Arms (1)

Study group

OTHER

Single arm and everyone gets the same treatment according the protocol

Drug: Neostigmine, Combinations

Interventions

Neostigmine, CombinationsDRUG

All patients have neostigmine induced recovery of neuromuscular block.

Study group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective surgery requiring general anaesthesia
  • Surgery is assumed to last more than 45 minutes
  • Body mass index less than 35kg/ m²

You may not qualify if:

  • Disease of central nervous system
  • Trauma of central nervous system
  • Disease affecting peripheral nervous system
  • Medication affecting peripheral nervous system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere University Hospital

Tampere, 33520, Finland

Location

MeSH Terms

Interventions

Neostigmine

Intervention Hierarchy (Ancestors)

Phenylammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsOnium Compounds

Study Officials

  • Maija Kalliomäki, Docent

    Tampere University Hospital

    STUDY DIRECTOR

  • Jarno Salminen, Licenciate

    Tampere University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single group with same study protocol to asses the incidence of postrecovery relaxation
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2019

First Posted

August 7, 2019

Study Start

April 8, 2020

Primary Completion

September 1, 2025

Study Completion

December 31, 2025

Last Updated

September 16, 2025

Record last verified: 2025-09

Locations

FI(1)