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

Completed

• Conditions: Onset Time of Cisatracurium; Duration of Action of Cisatracurium; Intubation Conditions
• Interventions: Drug: Cisatracurium

• Registration Number: NCT04921735
• 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 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.

Study Timeline

• Study First Submitted: 2021-06-05
• Study First Submitted QC: 2021-06-05
• Study First Posted: 2021-06-10
• Study Start: 2021-07-05
• Primary Completion: 2021-12-19
• Study Completion: 2021-12-19
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-25
• Last Update Posted: 2022-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Elderly	Cisatracurium	patients aged 80 years or older
young	Cisatracurium	patients aged 18-40 years

Primary Outcome Measures

Name	Time	Method
Onset time	within 10 minutes after administration	the time from the start of the injection of cisatracurium to train-of-four (TOF) count of 0 monitored by acceleromyography

Secondary Outcome Measures

Name	Time	Method
Duration of action	within 120 minutes after administration of cisatracurium	Duration of action is defined as time from start of cisatracurium injection to reappearance of TOF ratio \> 0.9.
intubation conditions	within 10 minutes after administration of cisatracurium	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 cisatracurium	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.

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark