NCT07524959

Brief 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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress8%
May 2026Jul 2026

First Submitted

Initial submission to the registry

March 28, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
18 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2026

Expected
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2026

Last Updated

April 13, 2026

Status Verified

January 1, 2026

Enrollment Period

3 months

First QC Date

March 28, 2026

Last Update Submit

April 6, 2026

Conditions

Neuromuscular Blocking Agents

Keywords

Neuromuscular MonitoringMivacuriumNeostigmineNeuromuscular Blocking Agents

Outcome Measures

Primary Outcomes (1)

  • The time from count 2 to TOFr recovery to 0.9

    Perioperative

Secondary Outcomes (6)

  • The time from count 2 to TOFr recovery to 0.7

    Perioperative

  • The time from count 2 to TOFr recovery to 0.4

    Perioperative

  • Mean Arterial Pressure

    Perioperative

  • Blood pressure

    Perioperative

  • Heart rate

    Perioperative

  • +1 more secondary outcomes

Study Arms (3)

Non-antagonistic group

NO INTERVENTION

No intervention

Count-2 antagonist group

EXPERIMENTAL

When relaxation monitoring is count 2, administer neostigmine.

Drug: Neostigmine

Train of four stimulation ratio (TOFr) 0.4 antagonist group

EXPERIMENTAL

When TOFr is 0.4, administer neostigmine.

Drug: Neostigmine

Interventions

NeostigmineDRUG

Administer neostigmine at a dose of 0.04 mg/kg (combined with 0.02 mg/kg atropine)

Count-2 antagonist groupTrain of four stimulation ratio (TOFr) 0.4 antagonist group

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Interventions

Neostigmine

Intervention Hierarchy (Ancestors)

Phenylammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsOnium Compounds

Study Officials

  • Guyan Wang

    Beijing Tongren Hospital

    STUDY DIRECTOR

Central Study Contacts

Haiyao Wu

CONTACT

0086 18171485811haiyaowu0105@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2026

First Posted

April 13, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

July 20, 2026

Study Completion (Estimated)

July 29, 2026

Last Updated

April 13, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)