Neuromuscular Blocking Agents in the Elderly

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)

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.

Study Overview

• Status: Completed
• Conditions: Elective Surgery
• Intervention / Treatment: Drug: Rocuronium

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

32 patients Group young: 16 patients age between 18-40 years receiving rocuronium 0.6 mg/kg Group elderly: 16 patients age >80 years receiving rocuronium 0.6 mg/kg

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Elderly (>80 years); Patients planned for elective surgery above 80 years	Drug: Rocuronium; 0.6 mg/kg; Other Names: Rocuronium 0.6 mg/kg
Younger (18-40 years); Patients planned for elective surgery between 18-40 years	Drug: Rocuronium; 0.6 mg/kg; Other Names: Rocuronium 0.6 mg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Onset Time	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.	Day 0, after induction of anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparing Intubating Conditions in the Two Groups	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	Day 0, after induction of anesthesia
Duration of Action	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 %.	Day 0, after induction of anesthesia

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Principal Investigator: Matias Vested, MD, Phd, Rigshospitalet, Denmark

Publications and helpful links

General Publications

• Bjerring C, Vested M, Arleth T, Eriksen K, Albrechtsen C, Rasmussen LS. Onset time and duration of action of rocuronium 0.6 mg/kg in patients above 80 years of age: A comparison with young adults. Acta Anaesthesiol Scand. 2020 Sep;64(8):1082-1088. doi: 10.1111/aas.13645. Epub 2020 Jun 18.

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2019
• Primary Completion (Actual): October 8, 2019
• Study Completion (Actual): October 8, 2019

Study Registration Dates

• First Submitted: February 25, 2019
• First Submitted That Met QC Criteria: February 27, 2019
• First Posted (Actual): February 28, 2019

Study Record Updates

• Last Update Posted (Actual): June 2, 2020
• Last Update Submitted That Met QC Criteria: May 18, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Rocuronium
• Other Study ID Numbers: H-18063017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No