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

Completed

• Conditions: Onset Time of Mivacurium, Duration of Action of Mivacurium
• Interventions: Drug: Mivacurium

• Registration Number: NCT05558137
• Lead Sponsor: Matias Vested

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.

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 Timeline

• Study First Submitted: 2022-09-24
• Study First Submitted QC: 2022-09-24
• Study First Posted: 2022-09-28
• Study Start: 2022-09-30
• Primary Completion: 2023-05-22
• Study Completion: 2023-05-25
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-03
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Elderly	Mivacurium	patients aged 80 years or older
Young	Mivacurium	patients aged 18-40 years

Primary Outcome Measures

Name	Time	Method
Onset time	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 Outcome Measures

Name	Time	Method
Duration of action	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.
Intubation conditions Fuchs-Buder	within 10 minutes after administration of mivacurium	intubation conditions are rated according to Fuchs-Buder score when TOF-ratio is 0.
Laryngeal morbidity	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.
Amount of ephedrine or metaoxedrine administered	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.
Intubation conditions IDS	within 10 minutes after administration of mivacurium	intubation conditions are rated according to intubating difficulty score IDS when TOF-ratio is 0.
Butyrylcholinesterase activity in a venous blood sample	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.

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark