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Completed

NCT Number: NCT03857750

Neuromuscular Blocking Agents in the Elderly

The number of elderly patients (>80 years) is increasing and a large proportion of these patients will require surgery and anaestheasia within the next decades.

During anaesthesia NMBAs are used to facilitate tracheal intubation, from former studies it is reported that elderly patients are more sensitive towards muscle relaxants.

It is unknown if there are differences in onset times of NMBAs between younger patients and elderly.

The aim of this study is to determine the onset time, duration of action and effect on intubating conditions for rocuronium 0.6 mg/kg in patients aged 18-40 years and in patiens >80 years. The hypothesis of this study is that rocuronium administered in elderly patients (>80 years) has a longer onset time compared to younger patients.

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Key information

Conditions

Elective Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rigshospitalet

Copenhagen, 2100, Denmark

About this study

The number of elderly patients (>80 years) is increasing and a large proportion of these patients will require surgery and anesthesia within the next decades. Elderly patients are at higher risk of major morbidity and mortality and are characterized by a reduction in cardiac output, liver function and renal function. These physiological changes influence pharmacodynamics and pharmacokinetics of drugs administered during anesthesia as for example neuromuscular blocking agents (NMBA).

During anesthesia NMBAs are used to facilitate tracheal intubation, establish muscle relaxation and suppress reflexes during surgery. Elderly patients are more sensitive towards muscle relaxants. In addition studies have reported prolonged duration of NMBAs and an observational study found that elderly patients are more prone to experience residual neuromuscular blockade in the post anesthesia care unit. However, most studies have been conducted in elderly below 80 years.

It is unknown if there are differences in onset times of NMBAs e.g. rocuronium, mivacurium and cisatracurium between younger patients and elderly. Onset time for NMBAs in the elderly is of importance since it may influence intubating conditions, especially during rapid sequence induction. For example it is unknown in the elderly if an increased dose of NMBA reduces the onset time. There remains a need for studies investigating the optimal dose for facilitating intubation in the elderly, both during rapid sequence induction and during elective procedures.

The aim of this study is to determine the onset time, duration of action and effect on intubating conditions for rocuronium 0.6 mg/kg in patients aged 18-40 years and in patients with age > 80 years. The hypothesis of this study is that rocuronium administered in elderly patients (>80 years) has a longer onset in the elderly 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 > 18 years old
  • Informed consent
  • Scheduled for elective surgery (>1 hour) under general anaesthesia with intubation and use of rocuronium.
  • American Society of Anaesthesiologists (ASA) physical status classification I to III
  • Can read and understand Danish

Exclusion criteria

  • Known allergy to rocuronium
  • Neuromuscular disease that may interfere with neuromuscular data
  • Indication for rapid sequence induction

Treatment and study plan

Rocuronium

Drug

0.6 mg/kg

Other names: Rocuronium 0.6 mg/kg

Primary outcomes

  1. Onset Time

    Time frame: Day 0, after induction of anesthesia

    The time from the end of rocuronium injection to train-of-four (TOF) count of 0 monitored by acceleromyography.

    The ulnar nerve was stimulated during the monitoring.

Secondary outcomes

  1. Comparing Intubating Conditions in the Two Groups

    Time frame: Day 0, after induction of anesthesia

    90 seconds after induction the conditions are rated by the Intubating Difficulty Scale (IDS).

    Easy is defined as IDS of 0. Slight is defined as IDS of 1 to 5 Moderate/Major is defined as >5

  2. Duration of Action

    Time frame: Day 0, after induction of anesthesia

    Time from end of rocuronium injection to TOF ratio >0.9. When the ratio between the first and last stimulation in TOF is above 90 %.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

An Observational Study of Rocuronium 0.6 mg/kg Comparing Onset Time, Duration of Action and Effect on Intubation Conditions in Younger (18 - 40 Years) and Elderly Patients (> 80 Years)

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 28, 2019
Registry last updated
Jun 2, 2020

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.

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