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Not yet recruiting NCT07524959

Antagonism of Neostigmine in Continuous Infusion of Mivacurium

No phase Interventional Neuromuscular Blocking Agents

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Neostigmine.
Who it may be relevant to
Registry conditions: Neuromuscular Blocking Agents. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Antagonism of Neostigmine in Continuous Infusion of Mivacurium: a Randomised Controlled Trial

Overview

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.

Interventions

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

Primary outcome measures

  • The time from count 2 to TOFr recovery to 0.9 [Time frame: Perioperative]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

China · 1 center
  • Beijing tongren Hospital, Capital Medical University — Beijing

Identifiers

NCT: NCT07524959 · TREC2024-KY102

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗