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

NCT ID: NCT05558137

Last Updated: 2023-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-30

Study Completion Date

2023-05-25

Brief Summary

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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

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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.

Conditions

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Onset Time of Mivacurium, Duration of Action of Mivacurium

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Elderly

patients aged 80 years or older

Mivacurium

Intervention Type 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

Young

patients aged 18-40 years

Mivacurium

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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mivacron

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Matias Vested

OTHER

Sponsor Role lead

Responsible Party

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Matias Vested

MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Matias Vested

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet University of Copenhagen

Locations

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Rigshospitalet

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-22028734

Identifier Type: -

Identifier Source: org_study_id

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