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

Matias Vested70 enrolled

Overview

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

Conditions

Onset Time of Mivacurium, Duration of Action of Mivacurium

Interventions

MivacuriumDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Rigshospitalet

Copenhagen, Denmark

Outcomes

Primary Outcomes

Onset time

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

Time frame: within 10 minutes after administration of mivacurium

Secondary Outcomes

Duration of action

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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: within 10 minutes after administration of mivacurium

Data from ClinicalTrials.gov

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