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Completed

NCT Number: NCT05558137

Mivacurium 0.2 mg/kg in Young (18 - 40 Years) and Elderly (= 80 Years) Patients

The aim of this study is to determine the onset time, duration of action and effect on intubation conditions of mivacurium 0.2 mg/kg in elderly patients with age ≥ 80 years and in young patients aged 18 - 40 years.

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Key information

Conditions

Onset Time of Mivacurium, Duration of Action of Mivacurium

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rigshospitalet

Copenhagen, 2100, Denmark

About this study

The aim of this study is to determine the onset time, duration of action and effect on intubation conditions of mivacurium 0.2 mg/kg in elderly patients with age ≥ 80 years and in young patients aged 18 - 40 years. The hypothesis of this study is that mivacurium administered in elderly patients (>80 years) has a longer onset time and duration of action compared to younger patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients ≥ 80 or ≥ 18 to ≤ 40 years of age
  • Informed consent
  • Scheduled for elective surgery under general anaesthesia (expected duration of anaesthesia > 1 hour) with intubation and use of mivacurium
  • American Society of Anesthesiologists (ASA) physical status classification I to III
  • Can read and understand Danish

Exclusion criteria

  • Known allergy to mivacurium
  • Neuromuscular disease that may interfere with neuromuscular monitoring
  • Indication for rapid sequence induction
  • Surgery in the prone position
  • Known butyrylcholinesterase deficiency

Treatment and study plan

Mivacurium

Drug

0.2 mg/kg based on ideal body weight calculated as height (cm) minus 105 for women and height (cm) minus 100 for men or actual body weight, whichever is lower

Other names: mivacron

Primary outcomes

  1. Onset time

    Time frame: within 10 minutes after administration of mivacurium

    the time from the start of the injection of mivacurium to train-of-four (TOF) count of 0 monitored by acceleromyography

Secondary outcomes

  1. Duration of action

    Time frame: within 90 minutes after administration of mivacurium

    Duration of action is defined as time from start of mivacurium injection to reappearance of TOF ratio > 0.9.

  2. Intubation conditions IDS

    Time frame: within 10 minutes after administration of mivacurium

    intubation conditions are rated according to intubating difficulty score IDS when TOF-ratio is 0.

  3. Intubation conditions Fuchs-Buder

    Time frame: within 10 minutes after administration of mivacurium

    intubation conditions are rated according to Fuchs-Buder score when TOF-ratio is 0.

  4. Laryngeal morbidity

    Time frame: 24 hours after surgery

    After 24 hours patients are asked about hoarseness and sore throat. Patients who experience either or both will be called 3 days postoperatively again. These two variables are assessed using a numeric ranking scale from 0 to 10.

  5. Amount of ephedrine or metaoxedrine administered

    Time frame: within 10 minutes after administration of mivacurium

    If ephedrine or metaoxedrine is administered after induction of anaesthesia and until the patient is ready for properly positioning for surgery, it will be noted in the CRF, as well as the amount administered. Changes in blood pressure or heart rate are treated according to local guidelines.

  6. Butyrylcholinesterase activity in a venous blood sample

    Time frame: within 7 days after administration of mivacurium

    Butyrylcholinesterase activity in a venous blood sample, and further determination of phenotype and genotype if the activity is low.

Sponsors and collaborators

Lead sponsor

Matias Vested

Other

Registry information

Official study title

An Observational Study of Mivacurium 0.2 mg/kg, Comparing Onset Time, Duration of Action and Effect on Intubating Conditions in Young (18 - 40 Years) and Elderly (= 80 Years) Patients

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 28, 2022
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.