Skip to main content
OpenTrials
Completed

NCT Number: NCT04921735

An Observational Study of Cisatracurium 0.15 mg/kg in Young 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Onset Time of Cisatracurium Duration of Action of Cisatracurium Intubation Conditions

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rigshospitalet

Copenhagen, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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

Primary outcomes

  1. Onset time

    Time frame: 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 outcomes

  1. Duration of action

    Time frame: 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.

  2. intubation conditions

    Time frame: within 10 minutes after administration of cistracurium

    intubation conditions are rated according to intubating difficulty score IDS when TOF-ratio is 0.

  3. intubation conditions

    Time frame: within 10 minutes after administration of cisatracurium

    intubation conditions are rated according to Fuchs-Buder score when TOF-ratio is 0.

  4. Laryngeal morbidity

    Time frame: 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.

  5. Amount of ephedrine or metaoxedrine administered

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Matias Vested

Other

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 10, 2021
Registry last updated
Jan 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.