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

Intubation Conditions Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04921735
• Other study ID #: Cisatracurium 2021
• Status: Completed
• Start date: July 5, 2021
• Est. completion date: December 19, 2021

Study information

• Verified date: January 2022
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 19, 2021
• Est. primary completion date: December 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Intubation Conditions

Intervention

Drug:
• Cisatracurium
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

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Matias Vested

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Onset time	the time from the start of the injection of cisatracurium to train-of-four (TOF) count of 0 monitored by acceleromyography	within 10 minutes after administration
Secondary	Duration of action	Duration of action is defined as time from start of cisatracurium injection to reappearance of TOF ratio > 0.9.	within 120 minutes after administration of cisatracurium
Secondary	intubation conditions	intubation conditions are rated according to intubating difficulty score IDS when TOF-ratio is 0.	within 10 minutes after administration of cistracurium
Secondary	intubation conditions	intubation conditions are rated according to Fuchs-Buder score when TOF-ratio is 0.	within 10 minutes after administration of cisatracurium
Secondary	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.	24 hours after surgery
Secondary	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.	within 10 minutes after administration of cisatracurium