NCT03857750

Neuromuscular Blocking Agents in the Elderly

Completed Results posted Last updated 2 June 2020

What this trial tests

trial testing Rocuronium in Elective Surgery in 32 participants. Completed in 8 October 2019.

Timeline

27 March 2019

Primary endpoint
8 October 2019

8 October 2019

Quick facts

Lead sponsor	Rigshospitalet, Denmark
Status	Completed
Study type	OBSERVATIONAL
Enrollment	32
Start date	27 March 2019
Primary completion	8 October 2019
Estimated completion	8 October 2019
Sites	1 location across Denmark

Drugs / interventions tested

• Rocuronium (ROCURONIUM) — full drug profile →

Conditions studied

• Elective Surgery — all drugs for Elective Surgery →

Sponsor

Rigshospitalet, Denmark

Who can join

18 and older, any sex, with Elective Surgery. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Onset Time Primary · 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.

Group	Value	95% CI
Elderly (>80 Years)	135	135 – 158
Younger (18-40 Years)	90	60 – 105

Comparing Intubating Conditions in the Two Groups Secondary · 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

Group	Value	95% CI
Elderly (>80 Years)	7
Younger (18-40 Years)	7
Elderly (>80 Years)	8
Younger (18-40 Years)	9
Elderly (>80 Years)	1
Younger (18-40 Years)	0

Duration of Action Secondary · 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 %.

Group	Value	95% CI
Elderly (>80 Years)	81	71 – 97
Younger (18-40 Years)	53	42 – 73

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Tracheal intubating conditions in elderly patients when train-of-four count is zero after rocuronium 0.6 or 0.9 mg/kg. A secondary analysis.
   Vested M, Hartoft M, Rasmussen LS. · · 2023 · cited 2× · PMID 37119324 · DOI 10.1007/s10877-023-01012-6
2. Shortened time to neuromuscular recovery with lower doses of rocuronium in elderly patients.
   Wadland SS, Rasmussen LS, Vested M. · · 2024 · PMID 38847412 · DOI 10.61409/a09230578