Onset Time of Mivacurium, Duration of Action of Mivacurium
Conditions
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.
Interventions
DRUGMivacurium
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
Sponsors
Matias Vested
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Denmark
Outcome results
None listed