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

NCT05558137 | Completed FDA Drug

• 1 other identifier: H-22028734
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Onset Time of Mivacurium, Duration of Action of Mivacurium

Outcome Measures

Primary Outcomes (1)

• Onset time

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

  within 10 minutes after administration of mivacurium

Secondary Outcomes (6)

• Duration of action

  within 90 minutes after administration of mivacurium

• Intubation conditions IDS

  within 10 minutes after administration of mivacurium

• Intubation conditions Fuchs-Buder

  within 10 minutes after administration of mivacurium

• Laryngeal morbidity

  24 hours after surgery

• Amount of ephedrine or metaoxedrine administered

  within 10 minutes after administration of mivacurium

Study Arms (2)

Elderly

patients aged 80 years or older

Drug: Mivacurium

Young

patients aged 18-40 years

Drug: Mivacurium

Interventions

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

Also known as: mivacron

Elderly; Young

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Elderly patients (≥ 80 years) and younger patients (18-40 years) scheduled for elective surgery

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Matias Vested: lead

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Butyrylcholinesterase activity determined by a blood sample

MeSH Terms

Interventions

Mivacurium

Intervention Hierarchy (Ancestors)

Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Matias Vested

  Rigshospitalet University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 24, 2022
• First Posted: September 28, 2022
• Study Start: September 30, 2022
• Primary Completion: May 22, 2023
• Study Completion: May 25, 2023
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)