Neuromuscular BlockadeNCT04512313
A Comparison of Rocuronium 0.3 mg/kg, and 0.9 mg/kg for Induction of Anesthesia in Elderly Patients.
A study testing Rocuronium 0,3mg/kg and Rocuronium 0,9mg/kg in people with Neuromuscular Blockade and Neuromuscular Blockade, Residual, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The number of elderly patients above 80 years is increasing and a large proportion of these patients will require surgery and anesthesia. During anesthesia neuromuscular blocking agents (NMBA) are administered to facilitate intubating conditions and reduce the trauma to the larynx and vocal cords. Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Neuromuscular Blockade, Neuromuscular Blockade, Residual, Anesthesia
- What is being tested?
- Rocuronium 0,3mg/kg and Rocuronium 0,9mg/kg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteDenmark
- Study dates
- 17 Dec 2020to 25 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 80
- Scheduled to elective surgery (expected duration time of surgery > 1 hour) under general anesthesia with intubation and use of rocuronium.
- American Society of Anesthesiologists (ASA) physical status classification I to III
- Informed consent (see appendix 1)
- Read and understand Danish
Who cannot join
- Neuromuscular disease
- Known allergy to rocuronium
- Prone position
- Indication for rapid sequence induction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-blinded Multicenter Randomized Interventional Study of Rocuronium 0.3 mg/kg, and 0.9 mg/kg Comparing Onset Time, Duration of Action and Effect on Intubating Conditions in Elderly Patients (≥ 80 Years).
The number of elderly patients above 80 years is increasing and a large proportion of these patients will require surgery and anesthesia.
During anesthesia neuromuscular blocking agents (NMBA) are administered to facilitate intubating conditions and reduce the trauma to the larynx and vocal cords. There is a risk of residual neuromuscular block when using NMBAs like rocuronium.
The aim of this study is to determine the onset time, duration of action and effect on intubating conditions after rocuronium 0.3 mg/kg and 0.9 mg/kg in patients with age ≥ 80 years.
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.
Rocuronium is a nondepolarizing neuromuscular blocking drug with an onset time of approximately 70 s and a clinical duration of action of approximately 50 min. according to previous studies. During anesthesia rocuronium is administered to facilitate intubating conditions and reduce the trauma to the larynx and vocal cords. Rocuronium is primarily metabolized in the liver (70 % unmetabolized via the bile) and excreted via the kidneys.
Onset time and duration of action of rocuronium should be assessed by objective neuromuscular monitoring. Also, this reduces the risk of residual neuromuscular block which is defined as a train of four (TOF) ratio less than 0.9. Especially elderly patients have a high incidence of residual neuromuscular block.
The collected data regarding the effect of rocuronium in elderly patients may change the treatment so these patients receive the correct dose for optimal intubating conditions. Also, detection of duration of action of different doses of rocuronium may reduce the risk of residual block and postoperative respiratory complications
The aim of this study is to determine the onset time, duration of action and effect on intubating conditions after rocuronium 0.3 mg/kg and 0.9 mg/kg in patients with age ≥ 80 years.
- Conditions
- Neuromuscular Blockade, Neuromuscular Blockade, Residual, Anesthesia, Intubation Complication
- Being tested
- Rocuronium 0,3mg/kg, Rocuronium 0,9mg/kg
- Medical subject headings
- Delayed Emergence from Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rocuronium 0,3mg/kgDrug
Also called Rocuronium
Rocuronium 0,3mg/kg at induction
Rocuronium 0,9mg/kgDrug
Also called Rocuronium
Rocuronium 0,9mg/kg at induction
| Study group | Role | What they receive |
|---|---|---|
| Group receiving rocuronium 0,3 mg/kg | Active comparator | Rocuronium 0,3 mg/kg at induction Receives: Drug: Rocuronium 0,3mg/kg |
| Group receiving rocuronium 0,9 mg/kg | Active comparator | Rocuronium 0,9 mg/kg at induction Receives: Drug: Rocuronium 0,9mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rocuronium onset time
Time from start of rocuronium injection to train-of-four (TOF) count of 0
Measured: intraoperative (From start of rocuronium injection to train-of-four (TOF) count of 0)
Secondary outcomes (2)
Duration of action of rocuronium
Time from start of rocuronium injection to reappearance of TOF ratio > 0.9.
Measured: intraoperative (Time from start of rocuronium injection to reappearance of TOF ratio > 0.9.)
Evaluation of intubating conditions ad modum Fuchs-Buder et al
Intubating conditions are rated by an intubating difficulty scale according to Fuchs-Buder et al.
Measured: intraoperative (From train-of-four (TOF) count of 0 till)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start17 Dec 2020
- Primary completion18 May 2021
- Study completion25 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular BlockadeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 34 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, Department of Anaesthesia, Head and Orthopaedics Centre, Rigshospitalet, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04512313
- Sponsor's protocol ID
- H-19079175
- Status last verified
- Jun 2021
- First submitted
- 11 Aug 2020
- Last updated
- 3 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 38847412
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-blinded Multicenter Randomized Interventional Study of Rocuronium 0.3 mg/kg, and 0.9 mg/kg Comparing Onset Time, Duration of Action and Effect on Intubating Conditions in Elderly Patients (≥ 80 Years).
- ClinicalTrials.gov ID
- NCT04512313
- Acronym / sponsor ID
- H-19079175
- Conditions
- Neuromuscular Blockade, Neuromuscular Blockade, Residual, Anesthesia, Intubation Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 17 Dec 2020 (actual)
- Primary completion
- 18 May 2021 (actual)
- Study completion
- 25 May 2021 (actual)
- First posted
- 13 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The number of elderly patients above 80 years is increasing and a large proportion of these patients will require surgery and anesthesia.
During anesthesia neuromuscular blocking agents (NMBA) are administered to facilitate intubating conditions and reduce the trauma to the larynx and vocal cords. There is a risk of residual neuromuscular block when using NMBAs like rocuronium.
The aim of this study is to determine the onset time, duration of action and effect on intubating conditions after rocuronium 0.3 mg/kg and 0.9 mg/kg in patients with age ≥ 80 years.
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.
Rocuronium is a nondepolarizing neuromuscular blocking drug with an onset time of approximately 70 s and a clinical duration of action of approximately 50 min. according to previous studies. During anesthesia rocuronium is administered to facilitate intubating conditions and reduce the trauma to the larynx and vocal cords. Rocuronium is primarily metabolized in the liver (70 % unmetabolized via the bile) and excreted via the kidneys.
Onset time and duration of action of rocuronium should be assessed by objective neuromuscular monitoring. Also, this reduces the risk of residual neuromuscular block which is defined as a train of four (TOF) ratio less than 0.9. Especially elderly patients have a high incidence of residual neuromuscular block.
The collected data regarding the effect of rocuronium in elderly patients may change the treatment so these patients receive the correct dose for optimal intubating conditions. Also, detection of duration of action of different doses of rocuronium may reduce the risk of residual block and postoperative respiratory complications
The aim of this study is to determine the onset time, duration of action and effect on intubating conditions after rocuronium 0.3 mg/kg and 0.9 mg/kg in patients with age ≥ 80 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group receiving rocuronium 0,3 mg/kg | Active comparator | Drug: Rocuronium 0,3mg/kgRocuronium 0,3 mg/kg at induction |
| Group receiving rocuronium 0,9 mg/kg | Active comparator | Drug: Rocuronium 0,9mg/kgRocuronium 0,9 mg/kg at induction |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age ≥ 80
- Scheduled to elective surgery (expected duration time of surgery > 1 hour) under general anesthesia with intubation and use of rocuronium.
- American Society of Anesthesiologists (ASA) physical status classification I to III
- Informed consent (see appendix 1)
- Read and understand Danish
Key exclusion criteria (4 listed)
- Neuromuscular disease
- Known allergy to rocuronium
- Prone position
- Indication for rapid sequence induction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rocuronium 0,3mg/kgAlso: RocuroniumRocuronium 0,3mg/kg at induction | Drug | Group receiving rocuronium 0,3 mg/kg |
| Rocuronium 0,9mg/kgAlso: RocuroniumRocuronium 0,9mg/kg at induction | Drug | Group receiving rocuronium 0,9 mg/kg |
Primary outcome
Rocuronium onset time
Time frame: intraoperative (From start of rocuronium injection to train-of-four (TOF) count of 0)
Time from start of rocuronium injection to train-of-four (TOF) count of 0
2 secondary outcomes
Duration of action of rocuronium
Time frame: intraoperative (Time from start of rocuronium injection to reappearance of TOF ratio > 0.9.)
Evaluation of intubating conditions ad modum Fuchs-Buder et al
Time frame: intraoperative (From train-of-four (TOF) count of 0 till)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
- Derived from this study: PubMed 38847412Wadland 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matias Vested, MD, PhD principal investigator
Department of Anaesthesia, Head and Orthopaedics Centre, Rigshospitalet, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rocuronium 0,3mg/kg and Rocuronium 0,9mg/kg in people with Neuromuscular Blockade and Neuromuscular Blockade, Residual, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rocuronium onset time (time frame: intraoperative (From start of rocuronium injection to train-of-four (TOF) count of 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04512313, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2021.