Elective Surgery
Conditions
Brief summary
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.
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.
Interventions
DRUGRocuronium
0.6 mg/kg
Sponsors
Rigshospitalet, Denmark
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Onset Time | 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
| Measure | Time frame | Description |
|---|---|---|
| Comparing Intubating Conditions in the Two Groups | 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 |
| Duration of Action | 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 %. |
Countries
Denmark
Participant flow
Recruitment details
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.
Pre-assignment details
Five of 37 patients were excluded due to rescheduling, rapid sequence induction, prone position and different anesthetic medication. 3 patients in each group have missing data on duration of action due to supplementary doses of rocuronium.
Participants by arm
| Arm | Count |
|---|---|
| Elderly (>80 Years) 16 patients planned for elective surgery above 80 years
Rocuronium: 0.6 mg/kg | 16 |
| Younger (18-40 Years) 16 patients planned for elective surgery between 18-40 years
Rocuronium: 0.6 mg/kg | 16 |
| Total | 32 |
Baseline characteristics
| Characteristic | Younger (18-40 Years) | Total | Elderly (>80 Years) |
|---|---|---|---|
| Age, Customized | 31 years | 60 years | 84 years |
| ASA ASA I | 6 Participants | 7 Participants | 1 Participants |
| ASA ASA II | 9 Participants | 17 Participants | 8 Participants |
| ASA ASA III | 1 Participants | 8 Participants | 7 Participants |
| Comorbidities Diabetes | 0 participants | 3 participants | 3 participants |
| Comorbidities Heart disease | 1 participants | 8 participants | 7 participants |
| Comorbidities Hypertension | 0 participants | 13 participants | 13 participants |
| Comorbidities Liver disease | 1 participants | 1 participants | 0 participants |
| Comorbidities Renal disease | 0 participants | 2 participants | 2 participants |
| Duration of anesthesia | 146 minutes | 154 minutes | 164 minutes |
| Duration of surgery | 101 minutes | 102 minutes | 104 minutes |
| Height | 174 centimeters | 169 centimeters | 164 centimeters |
| Medication Any | 11 participants | 26 participants | 15 participants |
| Medication Loop-diuretics or thiazids | 5 participants | 13 participants | 8 participants |
| Medication Magnesium | 0 participants | 1 participants | 1 participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Denmark | 16 participants | 32 participants | 16 participants |
| Sex: Female, Male Female | 13 Participants | 26 Participants | 13 Participants |
| Sex: Female, Male Male | 3 Participants | 6 Participants | 3 Participants |
| Weight | 72.5 kilograms | 73.5 kilograms | 74 kilograms |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 16 |
| other Total, other adverse events | 0 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 |
Outcome results
Primary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Elderly (>80 Years) | Onset Time | 135 seconds |
| Younger (18-40 Years) | Onset Time | 90 seconds |
Comparison: Comparing onset time of rocuroniump-value: <0.00195% CI: [40, 124]t-test, 2 sided
Comparison: 82p-value: <0.001Wilcoxon Mann-Whitney odd
Secondary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Elderly (>80 Years) | Comparing Intubating Conditions in the Two Groups | Easy | 7 Participants |
| Elderly (>80 Years) | Comparing Intubating Conditions in the Two Groups | Slight | 8 Participants |
| Elderly (>80 Years) | Comparing Intubating Conditions in the Two Groups | Moderate/Major | 1 Participants |
| Younger (18-40 Years) | Comparing Intubating Conditions in the Two Groups | Easy | 7 Participants |
| Younger (18-40 Years) | Comparing Intubating Conditions in the Two Groups | Slight | 9 Participants |
| Younger (18-40 Years) | Comparing Intubating Conditions in the Two Groups | Moderate/Major | 0 Participants |
Secondary
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
Population: 3 in each group had missing data due to supplementary doses of rocuronium
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Elderly (>80 Years) | Duration of Action | 81 minutes |
| Younger (18-40 Years) | Duration of Action | 53 minutes |
Comparison: Comparing duration of action of rocuroniump-value: <0.00195% CI: [14, 48]t-test, 2 sided
Comparison: Comparing duration of action of rocuroniump-value: 0.001Wilcoxon Mann-Whitney odd