An observational study in Elective Surgery, sponsored by Rigshospitalet, Denmark. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-02.
Sponsored by Rigshospitalet, Denmark · Observational
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.
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.
Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
Patients planned for elective surgery above 80 years
Drug: Rocuronium
Patients planned for elective surgery between 18-40 years
Drug: Rocuronium
0.6 mg/kg
Also known as: Rocuronium 0.6 mg/kg
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.
Time frame: Day 0, after induction of anesthesia
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
Time frame: 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 %.
Time frame: Day 0, after induction of anesthesia
Patients were included from the Departments of Anaesthesia, Centre of Head and Orthopaedics and Juliane Marie Centre, Rigshospitalet, University of Copenhagen, Denmark in the period of the 27th of March 2019 to 7th of November 2019.
| Milestone | Elderly (>80 Years) | Younger (18-40 Years) |
|---|---|---|
| Started | 16 | 16 |
| Completed | 16 | 16 |
| Not completed | 0 | 0 |
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.
| seconds | Elderly (>80 Years) | Younger (18-40 Years) |
|---|---|---|
| Onset Time | 135 (135 to 158) | 90 (60 to 105) |
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
| Participants | Elderly (>80 Years) | Younger (18-40 Years) |
|---|---|---|
| Easy | 7 | 7 |
| Slight | 8 | 9 |
| Moderate/Major | 1 | 0 |
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 %.
| minutes | Elderly (>80 Years) | Younger (18-40 Years) |
|---|---|---|
| Duration of Action | 81 (71 to 97) | 53 (42 to 73) |
Collected over From induction of anesthesia to departure from the operating room.. Non-serious events are listed at a 0.01% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Elderly (>80 Years) | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| Younger (18-40 Years) | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| Age, Customized(years) | Elderly (>80 Years) | Younger (18-40 Years) | Total |
|---|---|---|---|
| Median | 84 (81 to 85) | 31 (25 to 34) | 60 (31 to 84) |
| Sex: Female, Male(Participants) | Elderly (>80 Years) | Younger (18-40 Years) | Total |
|---|---|---|---|
| Female | 13 | 13 | 26 |
| Male | 3 | 3 | 6 |
| Race and Ethnicity Not Collected(Participants) | Elderly (>80 Years) | Younger (18-40 Years) | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Elderly (>80 Years) | Younger (18-40 Years) | Total |
|---|---|---|---|
| Denmark | 16 | 16 | 32 |
| Height(centimeters) | Elderly (>80 Years) | Younger (18-40 Years) | Total |
|---|---|---|---|
| Median | 164 (160 to 167) | 174 (170 to 179) | 169 (164 to 174) |
| Weight(kilograms) | Elderly (>80 Years) | Younger (18-40 Years) | Total |
|---|---|---|---|
| Median | 74 (60 to 79.8) | 72.5 (66 to 78.5) | 73.5 (62.5 to 79.3) |
| ASA(Participants) | Elderly (>80 Years) | Younger (18-40 Years) | Total |
|---|---|---|---|
| ASA I | 1 | 6 | 7 |
| ASA II | 8 | 9 | 17 |
| ASA III | 7 | 1 | 8 |
| Comorbidities(participants) | Elderly (>80 Years) | Younger (18-40 Years) | Total |
|---|---|---|---|
| Heart disease | 7 | 1 | 8 |
| Hypertension | 13 | 0 | 13 |
| Liver disease | 0 | 1 | 1 |
| Renal disease | 2 | 0 | 2 |
| Diabetes | 3 | 0 | 3 |
3 further baseline measures are reported on the registry.
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Rigshospitalet, Denmark