Antagonism of Neostigmine in Continuous Infusion of Mivacurium

April 6, 2026 updated by: Beijing Tongren Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100000
        • Beijing Tongren Hospital, Capital Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Non-antagonistic group
No intervention
Experimental: Count-2 antagonist group
When relaxation monitoring is count 2, administer neostigmine.
Drug: Neostigmine
Administer neostigmine at a dose of 0.04 mg/kg (combined with 0.02 mg/kg atropine)
Experimental: Train of four stimulation ratio (TOFr) 0.4 antagonist group
When TOFr is 0.4, administer neostigmine.
Drug: Neostigmine
Administer neostigmine at a dose of 0.04 mg/kg (combined with 0.02 mg/kg atropine)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The time from count 2 to TOFr recovery to 0.9
Time Frame: Perioperative
Perioperative

Secondary Outcome Measures

Outcome Measure
Time Frame
The time from count 2 to TOFr recovery to 0.7
Time Frame: Perioperative
Perioperative
The time from count 2 to TOFr recovery to 0.4
Time Frame: Perioperative
Perioperative
Mean Arterial Pressure
Time Frame: Perioperative
Perioperative
Blood pressure
Time Frame: Perioperative
Perioperative
Heart rate
Time Frame: Perioperative
Perioperative
Surgical duration
Time Frame: The start time and end time of the surgery
The start time and end time of the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tongren Hospital

Investigators

  • Study Director: Guyan Wang, Beijing Tongren Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

July 20, 2026

Study Completion (Estimated)

July 29, 2026

Study Registration Dates

First Submitted

March 28, 2026

First Submitted That Met QC Criteria

April 6, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TREC2024-KY102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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