Neuromuscular Blocking AgentsNCT07524959
Antagonism of Neostigmine in Continuous Infusion of Mivacurium
A study testing Neostigmine in people with Neuromuscular Blocking Agents, run by Beijing Tongren Hospital at 1 site in China.
Trial summary
In this study, the antagonism of neostigmine, a cholinesterase inhibitor, on continuous infusion of mivacurium during foot and ankle surgery under general anesthesia was investigated, and the appropriate time point of antagonism was explored. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neuromuscular Blocking Agents
- What is being tested?
- Neostigmine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 29 Jul 2026
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 - 65 years old;
- American Society of Anesthesiologists (ASA) physical stastus classification system: I-II;
- Body mass index (BMI) 18.5 - 30 kg/m2
- Patients with normal cholinesterase levels before the operation
Who cannot join
- Refusal to participate in the study;
- ASA classification of grade III or above;
- Severe organ dysfunction, difficult airway or neurological muscle disorders;
- Taking drugs that affect neuromuscular monitoring or neuromuscular conduction function;
- Allergic to the test drug or having other contraindications;
- Pregnant and lactating women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, 100000
Haiyaao Wu, 008618171485811, haiyaowu0105@163.com
About this study
Official title: Antagonism of Neostigmine in Continuous Infusion of Mivacurium: a Randomised Controlled Trial
In this study, the antagonism of neostigmine, a cholinesterase inhibitor, on continuous infusion of mivacurium during foot and ankle surgery under general anesthesia was investigated, and the appropriate time point of antagonism was explored.
Read the detailed description
Mivacurium is currently the shortest-acting benzylisoquinoline nondepolarizing muscular relaxant in clinical practice, which is suitable for short surgery. Its continuous infusion can also be used in medium-term surgery with uncertain operation time, which can accelerate the recovery of postoperative muscle relaxation. Whether continuous infusion of mivacurium requires antagonism and the appropriate time point of antagonism is controversial.
- Conditions
- Neuromuscular Blocking Agents
- Being tested
- Neostigmine
- Keywords
- Neuromuscular Monitoring, Mivacurium, Neostigmine, Neuromuscular Blocking Agents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeostigmineDrug
Administer neostigmine at a dose of 0.04 mg/kg (combined with 0.02 mg/kg atropine)
| Study group | Role | What they receive |
|---|---|---|
| Non-antagonistic group | No intervention | No intervention |
| Count-2 antagonist group | Experimental | When relaxation monitoring is count 2, administer neostigmine. Receives: Drug: Neostigmine |
| Train of four stimulation ratio (TOFr) 0.4 antagonist group | Experimental | When TOFr is 0.4, administer neostigmine. Receives: Drug: Neostigmine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time from count 2 to TOFr recovery to 0.9
Measured: Perioperative
Secondary outcomes (6)
The time from count 2 to TOFr recovery to 0.7
Measured: Perioperative
The time from count 2 to TOFr recovery to 0.4
Measured: Perioperative
Mean Arterial Pressure
Measured: Perioperative
Blood pressure
Measured: Perioperative
Heart rate
Measured: Perioperative
Surgical duration
Measured: The start time and end time of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion20 Jul 2026 (estimated)
- Study completion29 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular Blocking AgentsStudies of the same condition, open and under way.
- More trials run by Beijing Tongren 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guyan Wang, Study director, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07524959
- Sponsor's protocol ID
- TREC2024-KY102
- Status last verified
- Jan 2026
- First submitted
- 28 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antagonism of Neostigmine in Continuous Infusion of Mivacurium: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07524959
- Acronym / sponsor ID
- TREC2024-KY102
- Conditions
- Neuromuscular Blocking Agents
- Keywords
- Neuromuscular Monitoring, Mivacurium, Neostigmine, Neuromuscular Blocking Agents
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 20 Jul 2026 (estimated)
- Study completion
- 29 Jul 2026 (estimated)
- First posted
- 13 Apr 2026 (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.
In this study, the antagonism of neostigmine, a cholinesterase inhibitor, on continuous infusion of mivacurium during foot and ankle surgery under general anesthesia was investigated, and the appropriate time point of antagonism was explored.
Detailed description
Mivacurium is currently the shortest-acting benzylisoquinoline nondepolarizing muscular relaxant in clinical practice, which is suitable for short surgery. Its continuous infusion can also be used in medium-term surgery with uncertain operation time, which can accelerate the recovery of postoperative muscle relaxation. Whether continuous infusion of mivacurium requires antagonism and the appropriate time point of antagonism is controversial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-antagonistic group | No intervention | –No intervention |
| Count-2 antagonist group | Experimental | Drug: NeostigmineWhen relaxation monitoring is count 2, administer neostigmine. |
| Train of four stimulation ratio (TOFr) 0.4 antagonist group | Experimental | Drug: NeostigmineWhen TOFr is 0.4, administer neostigmine. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 - 65 years old;
- American Society of Anesthesiologists (ASA) physical stastus classification system: I-II;
- Body mass index (BMI) 18.5 - 30 kg/m2
- Patients with normal cholinesterase levels before the operation
Key exclusion criteria (6 listed)
- Refusal to participate in the study;
- ASA classification of grade III or above;
- Severe organ dysfunction, difficult airway or neurological muscle disorders;
- Taking drugs that affect neuromuscular monitoring or neuromuscular conduction function;
- Allergic to the test drug or having other contraindications;
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 |
|---|---|---|
| NeostigmineAdminister neostigmine at a dose of 0.04 mg/kg (combined with 0.02 mg/kg atropine) | Drug | Count-2 antagonist group, Train of four stimulation ratio (TOFr) 0.4 antagonist group |
Primary outcome
The time from count 2 to TOFr recovery to 0.9
Time frame: Perioperative
6 secondary outcomes
The time from count 2 to TOFr recovery to 0.7
Time frame: Perioperative
The time from count 2 to TOFr recovery to 0.4
Time frame: Perioperative
Mean Arterial Pressure
Time frame: Perioperative
Blood pressure
Time frame: Perioperative
Heart rate
Time frame: Perioperative
Surgical duration
Time frame: The start time and end time of the surgery
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 13 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Guyan Wang study director
Beijing Tongren 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 in people with Neuromuscular Blocking Agents, run by Beijing Tongren Hospital at 1 site in China.
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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 13 Apr 2026. 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 China. 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?
Contact Haiyao Wu (0086 18171485811, haiyaowu0105@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time from count 2 to TOFr recovery to 0.9 (time frame: Perioperative). 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 13 Apr 2026.