Elective SurgeryNCT03857750
Neuromuscular Blocking Agents in the Elderly
An observational study of Elective Surgery, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elective Surgery
- What is being tested?
- Rocuronium
- How many people
- 32 participants
- Where
- 1 siteDenmark
- Study dates
- 27 Mar 2019to 8 Oct 2019
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Known allergy to rocuronium
- Neuromuscular disease that may interfere with neuromuscular data
- Indication for rapid sequence induction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Elective Surgery
- Being tested
- Rocuronium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RocuroniumDrug
Also called Rocuronium 0.6 mg/kg
0.6 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Elderly (>80 years) | Patients planned for elective surgery above 80 years Receives: Drug: Rocuronium | |
| Younger (18-40 years) | Patients planned for elective surgery between 18-40 years Receives: Drug: Rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0, after induction of anesthesia
Secondary outcomes (2)
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
Measured: 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 %.
Measured: Day 0, after induction of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study start27 Mar 2019
- Primary completion8 Oct 2019
- Study completion8 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Elective SurgeryStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matias Vested, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Matias Vested, MD, Phd, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03857750
- Sponsor's protocol ID
- H-18063017
- Status last verified
- May 2020
- First submitted
- 25 Feb 2019
- Last updated
- 2 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38847412Bjerring 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.
PubMed 32462665