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An Observational Study of Cisatracurium 0.15 mg/kg in Young and Elderly (≥ 80 Years) Patients.

An Observational Study of Cisatracurium 0.15 mg/kg, Comparing Onset Time, Duration of Action and Effect on Intubating Conditions in Young (18 - 40 Years) and Elderly (≥ 80 Years) Patients.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04921735
Enrollment
60
Registered
2021-06-10
Start date
2021-07-05
Completion date
2021-12-19
Last updated
2022-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Duration of Action of Cisatracurium, Intubation Conditions, Onset Time of Cisatracurium

Brief summary

The aim of this study is to determine the onset time, duration of action and effect on intubation conditions of cisatracurium 0.15 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 cisatracurium 0.15 mg/kg in elderly patients with age ≥ 80 years and in young patients aged 18 - 40 years. The hypothesis of this study is that cisatracurium administered in elderly patients (\>80 years) has a longer onset time and duration of action compared to younger patients.

Interventions

DRUGCisatracurium

0.15 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
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
No

Inclusion criteria

1. Patients ≥ 80 or ≥18 - ≤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 cisatracurium 4. American Society of Anaesthesiologists (ASA) physical status classification I to III 5. Can read and understand Danish

Exclusion criteria

1. Known allergy to cisatracurium 2. Neuromuscular disease 3. Indication for rapid sequence induction 4. Surgery in the prone position

Design outcomes

Primary

MeasureTime frameDescription
Onset timewithin 10 minutes after administrationthe time from the start of the injection of cisatracurium to train-of-four (TOF) count of 0 monitored by acceleromyography

Secondary

MeasureTime frameDescription
Duration of actionwithin 120 minutes after administration of cisatracuriumDuration of action is defined as time from start of cisatracurium injection to reappearance of TOF ratio \> 0.9.
intubation conditionswithin 10 minutes after administration of cistracuriumintubation conditions are rated according to intubating difficulty score IDS when TOF-ratio is 0.
Laryngeal morbidity24 hours after surgeryAfter 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 administeredwithin 10 minutes after administration of cisatracuriumIf 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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026