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.

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.

Study Overview

• Status: Completed
• Conditions: Intubation Conditions; Onset Time of Cisatracurium; Duration of Action of Cisatracurium
• Intervention / Treatment: Drug: Cisatracurium

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 Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Elderly patients (≥ 80 years) and younger patients (18-40 years) scheduled for elective surgery

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Elderly; patients aged 80 years or older	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
young; patients aged 18-40 years	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
intubation conditions	intubation conditions are rated according to intubating difficulty score IDS when TOF-ratio is 0.	within 10 minutes after administration of cistracurium
intubation conditions	intubation conditions are rated according to Fuchs-Buder score when TOF-ratio is 0.	within 10 minutes after administration of cisatracurium
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

Collaborators and Investigators

• Sponsor: Matias Vested

Publications and helpful links

General Publications

• Vested M, Kristensen CM, Pape P, Vang M, Hartoft M, Hjelmdal C, Rasmussen LS. Comparison of onset time, duration of action, and intubating conditions after cisatracurium 0.15 mg/kg in young and elderly patients. BMC Anesthesiol. 2022 Nov 7;22(1):339. doi: 10.1186/s12871-022-01881-5.

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2021
• Primary Completion (Actual): December 19, 2021
• Study Completion (Actual): December 19, 2021

Study Registration Dates

• First Submitted: June 5, 2021
• First Submitted That Met QC Criteria: June 5, 2021
• First Posted (Actual): June 10, 2021

Study Record Updates

• Last Update Posted (Actual): January 26, 2022
• Last Update Submitted That Met QC Criteria: January 25, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Blocking Agents; Cisatracurium
• Other Study ID Numbers: Cisatracurium 2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No