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

NCT04921735 | Completed FDA Drug

• 1 other identifier: Cisatracurium 2021
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Duration of action

  within 120 minutes after administration of cisatracurium

• intubation conditions

  within 10 minutes after administration of cistracurium

• intubation conditions

  within 10 minutes after administration of cisatracurium

• Laryngeal morbidity

  24 hours after surgery

• Amount of ephedrine or metaoxedrine administered

  within 10 minutes after administration of cisatracurium

Study Arms (2)

Elderly

patients aged 80 years or older

Drug: Cisatracurium

young

patients aged 18-40 years

Drug: Cisatracurium

Interventions

Cisatracurium DRUG

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

Elderly; young

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Patients ≥ 80 or ≥18 - ≤40 years of age
• Informed consent
• Scheduled for elective surgery under general anaesthesia (expected duration of anaesthesia \> 1 hour) with intubation and use of cisatracurium
• American Society of Anaesthesiologists (ASA) physical status classification I to III
• Can read and understand Danish

You may not qualify if:

• Known allergy to cisatracurium
• Neuromuscular disease
• Indication for rapid sequence induction
• Surgery in the prone position

Sponsors & Collaborators

• Matias Vested: lead

Study Sites (1)

Rigshospitalet

Copenhagen, Denmark

Location

Related Publications (1)

• 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.

  PMID: 36344924 DERIVED

MeSH Terms

Interventions

cisatracurium

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 5, 2021
• First Posted: June 10, 2021
• Study Start: July 5, 2021
• Primary Completion: December 19, 2021
• Study Completion: December 19, 2021
• Last Updated: January 26, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)