Neuromuscular BlockadeNCT04048655
Reversal of Neuromuscular Blockade During the General Anaesthesia
A study testing Neostigmine, Combinations in people with Neuromuscular Blockade, run by Tampere University Hospital at 1 site in Finland.
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%). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuromuscular Blockade
- What is being tested?
- Neostigmine, Combinations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFinland
- Study dates
- 8 Apr 2020to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elective surgery requiring general anaesthesia
- Surgery is assumed to last more than 45 minutes
- Body mass index less than 35kg/ m²
Who cannot join
- Disease of central nervous system
- Trauma of central nervous system
- Disease affecting peripheral nervous system
- Medication affecting peripheral nervous system
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Neuromuscular Blockade
- Being tested
- Neostigmine, Combinations
- Keywords
- neuromuscular blockade, neostigmine, muscle relaxation, train of four, rocuronium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neostigmine, CombinationsDrug
All patients have neostigmine induced recovery of neuromuscular block.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Other | Single arm and everyone gets the same treatment according the protocol Receives: Drug: Neostigmine, Combinations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postrecovery relaxation
Number of patients (if any) with postrecovery relaxation divided by a number of all patients
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start8 Apr 2020
- Primary completion1 Sep 2025
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular BlockadeStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group with same study protocol to asses the incidence of postrecovery relaxation
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maija Kalliomäki, Docent, Study director, Tampere University HospitalJarno Salminen, Licenciate, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04048655
- Sponsor's protocol ID
- R19095M
- Status last verified
- Sep 2025
- First submitted
- 5 Aug 2019
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reversal of Neuromuscular Blockade During the General Anaesthesia
- ClinicalTrials.gov ID
- NCT04048655
- Acronym / sponsor ID
- R19095M
- Conditions
- Neuromuscular Blockade
- Keywords
- neuromuscular blockade, neostigmine, muscle relaxation, train of four, rocuronium
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- 8 Apr 2020 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group with same study protocol to asses the incidence of postrecovery relaxation
| Arm | Type | Receives |
|---|---|---|
| Study group | Other | Drug: Neostigmine, CombinationsSingle arm and everyone gets the same treatment according the protocol |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective surgery requiring general anaesthesia
- Surgery is assumed to last more than 45 minutes
- Body mass index less than 35kg/ m²
Key exclusion criteria (4 listed)
- Disease of central nervous system
- Trauma of central nervous system
- Disease affecting peripheral nervous system
- Medication affecting peripheral nervous system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neostigmine, CombinationsAll patients have neostigmine induced recovery of neuromuscular block. | Drug | Study group |
Primary outcome
Incidence of postrecovery relaxation
Time frame: 30 minutes
Number of patients (if any) with postrecovery relaxation divided by a number of all patients
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maija Kalliomäki, Docent study director
Tampere University Hospital
Jarno Salminen, Licenciate principal investigator
Tampere University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neostigmine, Combinations in people with Neuromuscular Blockade, run by Tampere University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postrecovery relaxation (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.