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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elderly (>80 years) | Patients planned for elective surgery above 80 years |
| |
| Younger (18-40 years) | Patients planned for elective surgery between 18-40 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rocuronium | Drug | 0.6 mg/kg |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Matias Vested, MD, Phd | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38847412 | Derived | Wadland SS, Rasmussen LS, Vested M. Shortened time to neuromuscular recovery with lower doses of rocuronium in elderly patients. Dan Med J. 2024 May 13;71(6):A09230578. doi: 10.61409/A09230578. | |
| 32462665 | Derived | 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. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Elderly (>80 Years) | 16 patients planned for elective surgery above 80 years Rocuronium: 0.6 mg/kg |
| FG001 | Younger (18-40 Years) | 16 patients planned for elective surgery between 18-40 years Rocuronium: 0.6 mg/kg |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Elderly (>80 Years) | 16 patients planned for elective surgery above 80 years Rocuronium: 0.6 mg/kg |
| BG001 | Younger (18-40 Years) | 16 patients planned for elective surgery between 18-40 years Rocuronium: 0.6 mg/kg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Inter-Quartile Range | seconds | Day 0, after induction of anesthesia |
|
From induction of anesthesia to departure from the operating room.
In both groups the patients will receive rocuronium in a dose aiming to provide optimal intubating conditions. It is not regarded as a disadvantage to use rocuronium, since the effect is monitored through surgery and if needed fully reversed by a reversal agent upon end of surgery.
It is an observational study why the patients mortality was not affected by the trial. Furthermore, patients at high risk for serious adverse events were excluded due to the criteria.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Elderly (>80 Years) | 16 patients planned for elective surgery above 80 years Rocuronium: 0.6 mg/kg |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Matias Vested | Rigshospitalet | +4524464955 | matiasvested@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 6, 2018 | Jan 25, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000077123 | Rocuronium |
| ID | Term |
|---|---|
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Median | Inter-Quartile Range | centimeters |
|
| Weight | Median | Inter-Quartile Range | kilograms |
|
| ASA | American Society of Anesthesiologists physical status was used to investigate if the two groups were similar concerning comorbidities. ASA 1: no riskfactors or comorbidities ASA 2: slight riskfactors or/and comorbidites ASA 3: moderate riskfactors or/and comorbidities | Count of Participants | Participants |
|
| Comorbidities | Number | participants |
|
| Medication | Number | participants |
|
| Duration of anesthesia | Median | Inter-Quartile Range | minutes |
|
| Duration of surgery | Median | Inter-Quartile Range | minutes |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| 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 | Posted | Count of Participants | Participants | Day 0, after induction of anesthesia |
|
|
|
| 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 %. | 3 in each group had missing data due to supplementary doses of rocuronium | Posted | Median | Inter-Quartile Range | minutes | Day 0, after induction of anesthesia |
|
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Younger (18-40 Years) | 16 patients planned for elective surgery between 18-40 years Rocuronium: 0.6 mg/kg | 0 | 16 | 0 | 16 | 0 | 16 |
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| D011083 |
| Polycyclic Compounds |
| ASA III |
|
| Moderate/Major |
|
| 0.001 |
| Odds |
| 6.35 |
| 2-Sided |
95% Confidence interval is 2.59 to infinity. |
| Other |