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

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

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.

Study Overview

• Status: Completed
• Conditions: Onset Time of Mivacurium, Duration of Action of Mivacurium
• Intervention / Treatment: Drug: Mivacurium

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Known allergy to mivacurium
2. Neuromuscular disease that may interfere with neuromuscular monitoring
3. Indication for rapid sequence induction
4. Surgery in the prone position
5. Known butyrylcholinesterase deficiency

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Elderly; patients aged 80 years or older	Drug: Mivacurium; 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
Young; patients aged 18-40 years	Drug: Mivacurium; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of action	Duration of action is defined as time from start of mivacurium injection to reappearance of TOF ratio > 0.9.	within 90 minutes after administration of mivacurium
Intubation conditions IDS	intubation conditions are rated according to intubating difficulty score IDS when TOF-ratio is 0.	within 10 minutes after administration of mivacurium
Intubation conditions Fuchs-Buder	intubation conditions are rated according to Fuchs-Buder score when TOF-ratio is 0.	within 10 minutes after administration of mivacurium
Laryngeal morbidity	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.	24 hours after surgery
Amount of ephedrine or metaoxedrine administered	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.	within 10 minutes after administration of mivacurium
Butyrylcholinesterase activity in a venous blood sample	Butyrylcholinesterase activity in a venous blood sample, and further determination of phenotype and genotype if the activity is low.	within 7 days after administration of mivacurium

Collaborators and Investigators

• Sponsor: Matias Vested
• Investigators: Principal Investigator: Matias Vested, Rigshospitalet University of Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2022
• Primary Completion (Actual): May 22, 2023
• Study Completion (Actual): May 25, 2023

Study Registration Dates

• First Submitted: September 24, 2022
• First Submitted That Met QC Criteria: September 24, 2022
• First Posted (Actual): September 28, 2022

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 3, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Mivacurium
• Other Study ID Numbers: H-22028734

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: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No