Neuromuscular BlockadePhase 4NCT04287426
A Comparison of Rocuronium 0.6 mg/kg and Remifentanil 2 µg/kg in Elderly Patients Over 80 Years
A Phase 4 study testing Rocuronium 0.6 mg/kg and Remifentanil 2 µg/kg in people with Neuromuscular Blockade and Intubation Complication, run by Copenhagen University Hospital, Rigshospitalet at 2 sites 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, Intubation Complication, Anesthesia
- What is being tested?
- Rocuronium 0.6 mg/kg and Remifentanil 2 µg/kg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 2 sitesDenmark
- Study dates
- 11 Mar 2020to 13 Dec 2020
- Phase
- Phase 4
- 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 for elective operations (expected duration of anesthesia > 1 hour) under general anesthesia with intubation
- American Society of Anesthesiologists physical status classification (ASA) I to III
- Informed consent (see appendix 1)
- Read and understand Danish
Who cannot join
- Neuromuscular disease
- Known allergy to rocuronium, remifentanil or sugammadex
- Rapid sequence induction
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Rigshospitalet
Copenhagen, 2100
Rigshospitalet, Glostrup
Glostrup Municipality, 2600
About this study
Official title: A Single-blinded Multicenter Randomized Study Comparing Intubating Conditions After Either Rocuronium 0.6 mg/kg or Remifentanil 2 µg/kg in Elderly Patients
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.
Read more
Remifentanil is a fentanyl analogue commonly used for induction since it also facilitates intubation. There is no risk of residual neuromuscular block, nonetheless circulatory side effects have been seen.
It is unknown which is superior concerning intubating conditions in elderly patients. Therefore, the aim of this study is to determine the effect on intubating conditions and laryngeal morbidity after either rocuronium 0.6 mg/kg or remifentanil 2 µg/kg in patients with age ≥ 80 years. The hypothesis of this study is that rocuronium 0.6 mg/kg provides a higher proportion with excellent intubating conditions compared to remifentanil 2 µg/kg.
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.
During anesthesia neuromuscular blocking agents (NMBA) are administered to facilitate intubating conditions and reduce the trauma to the larynx and vocal cords. Studies suggests that avoidance of neuromuscular blocking agents (NMBAs) increases the risk of difficult tracheal intubation and leads to impaired intubating conditions with direct laryngoscopy. Furthermore, avoidance of NMBA significantly increases the risk of upper airway discomfort or injury. Even low doses of rocuronium may be associated with a significant improvement of intubating conditions.
Remifentanil is a fentanyl analogue commonly used for induction since it also facilitates intubation. There is no risk of residual neuromuscular block, nonetheless circulatory side effects have been seen.
The possible benefit in this trial is to investigate whether rocuronium 0.6 mg/kg or remifentanil 2 µg/kg provides best intubating conditions in the elderly. This may result in different intubating difficulty scores between the two groups of elderly patients. The results may help to detect the optimal method for intubation of the trachea in elderly patients.
The aim of this study is to determine the effect on intubating conditions and laryngeal morbidity after either rocuronium 0.6 mg/kg or remifentanil 2 µg/kg in patients with age ≥ 80 years. The hypothesis of this study is that rocuronium 0.6 mg/kg provides a higher proportion with excellent intubating conditions compared to remifentanil 2 µg/kg.
- Conditions
- Neuromuscular Blockade, Intubation Complication, Anesthesia
- Being tested
- Rocuronium 0.6 mg/kg, Remifentanil 2 µg/kg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rocuronium 0.6 mg/kgDrug
Rocuronium 0.6 mg/kg is compared to patients with 2 µg/kg remifentanil
Remifentanil 2 µg/kgDrug
Rocuronium 0.6 mg/kg is compared to patients with 2 µg/kg remifentanil
| Study group | Role | What they receive |
|---|---|---|
| Group receiving rocuronium at induction | Active comparator | Rocuronium 0,6 mg/kg at induction Receives: Drug: Rocuronium 0.6 mg/kg |
| Group receiving remifentanil at induction | Active comparator | Remifentanil 2 μg/kg at induction Receives: Drug: Remifentanil 2 µg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of intubating conditions ad modum Fuchs-Buder et al
Occurrence of excellent intubating conditions 2 minutes after start of administration of 0.6 mg/kg rocuronium or 2 µg/kg remifentanil, scored according to Fuchs-Buder et al. The intubating conditions will be classified as excellent if all qualities are excellent, good if all qualities are either excellent or good and poor if the presence of a single quality is listed as poor.
Measured: 2 minutes after start of administration of trial medication
Secondary outcomes (3)
Subjective side effects of laryngoscopy
After 24 hours patients are asked about hoarseness and sore throat. The patients who experience either or both will be called 3 days postoperatively again. These two variables are assessed using a numeric ranking scale.
Measured: 24 hours postoperatively and 3 days postoperatively
Dose of ephedrine or dose of metaoxedrine administered
If ephedrine and/or metaoxedrine is administered in the time period from induction until the patient is ready to be positioned for surgery it will be noted in the CRF. The amount administered will also be noted in the CRF. Changes in blood pressure are treated according to local guidelines.
Measured: From induction until the patient is ready to be positioned for surgery, ranging from 5 minutes up to 1 hour.
Intubating conditions according to IDS
Another way of rating intubating conditions are by an intubating difficulty scale (Table 2) (20) 2 minutes after injection of rocuronium/remifentanil. The investigator performing the intubation will be handed the CRF where he/she will fill out Table 2. Furthermore, investigator will note if a stylet or video laryngoscope has been used.
Measured: 2 minutes after start of administration of trial medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start11 Mar 2020
- Primary completion10 Dec 2020
- Study completion13 Dec 2020
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 78 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, DenmarkAnne Marie Sørensen, MD, PhD, Principal investigator, Department of Neuroanaesthesia, Rigshospitalet, Glostrup, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04287426
- Sponsor's protocol ID
- H-19070343
- Other IDs
- 2019-004121-25, 2019
- Status last verified
- Dec 2020
- First submitted
- 27 Jan 2020
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vested M, Sorensen AM, Bjerring C, Christensen RE, Dinesen F, Vang M, Gilvanoff A, Hansen TE, Nielsen T, Rasmussen LS. A blinded randomized study comparing intubating conditions after either rocuronium 0.6 mg.kg-1 or remifentanil 2 microg.kg-1 in elderly patients. Acta Anaesthesiol Scand. 2021 Nov;65(10):1367-1373. doi: 10.1111/aas.13957. Epub 2021 Sep 5.
PubMed 34310692
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-blinded Multicenter Randomized Study Comparing Intubating Conditions After Either Rocuronium 0.6 mg/kg or Remifentanil 2 µg/kg in Elderly Patients
- ClinicalTrials.gov ID
- NCT04287426
- Acronym / sponsor ID
- H-19070343
- Conditions
- Neuromuscular Blockade, Intubation Complication, Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 11 Mar 2020 (actual)
- Primary completion
- 10 Dec 2020 (actual)
- Study completion
- 13 Dec 2020 (actual)
- First posted
- 27 Feb 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.
Remifentanil is a fentanyl analogue commonly used for induction since it also facilitates intubation. There is no risk of residual neuromuscular block, nonetheless circulatory side effects have been seen.
It is unknown which is superior concerning intubating conditions in elderly patients. Therefore, the aim of this study is to determine the effect on intubating conditions and laryngeal morbidity after either rocuronium 0.6 mg/kg or remifentanil 2 µg/kg in patients with age ≥ 80 years. The hypothesis of this study is that rocuronium 0.6 mg/kg provides a higher proportion with excellent intubating conditions compared to remifentanil 2 µg/kg.
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.
During anesthesia neuromuscular blocking agents (NMBA) are administered to facilitate intubating conditions and reduce the trauma to the larynx and vocal cords. Studies suggests that avoidance of neuromuscular blocking agents (NMBAs) increases the risk of difficult tracheal intubation and leads to impaired intubating conditions with direct laryngoscopy. Furthermore, avoidance of NMBA significantly increases the risk of upper airway discomfort or injury. Even low doses of rocuronium may be associated with a significant improvement of intubating conditions.
Remifentanil is a fentanyl analogue commonly used for induction since it also facilitates intubation. There is no risk of residual neuromuscular block, nonetheless circulatory side effects have been seen.
The possible benefit in this trial is to investigate whether rocuronium 0.6 mg/kg or remifentanil 2 µg/kg provides best intubating conditions in the elderly. This may result in different intubating difficulty scores between the two groups of elderly patients. The results may help to detect the optimal method for intubation of the trachea in elderly patients.
The aim of this study is to determine the effect on intubating conditions and laryngeal morbidity after either rocuronium 0.6 mg/kg or remifentanil 2 µg/kg in patients with age ≥ 80 years. The hypothesis of this study is that rocuronium 0.6 mg/kg provides a higher proportion with excellent intubating conditions compared to remifentanil 2 µg/kg.
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 at induction | Active comparator | Drug: Rocuronium 0.6 mg/kgRocuronium 0,6 mg/kg at induction |
| Group receiving remifentanil at induction | Active comparator | Drug: Remifentanil 2 µg/kgRemifentanil 2 μg/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 for elective operations (expected duration of anesthesia > 1 hour) under general anesthesia with intubation
- American Society of Anesthesiologists physical status classification (ASA) I to III
- Informed consent (see appendix 1)
- Read and understand Danish
Key exclusion criteria (3 listed)
- Neuromuscular disease
- Known allergy to rocuronium, remifentanil or sugammadex
- 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 0.6 mg/kgRocuronium 0.6 mg/kg is compared to patients with 2 µg/kg remifentanil | Drug | Group receiving rocuronium at induction |
| Remifentanil 2 µg/kgRocuronium 0.6 mg/kg is compared to patients with 2 µg/kg remifentanil | Drug | Group receiving remifentanil at induction |
Primary outcome
Evaluation of intubating conditions ad modum Fuchs-Buder et al
Time frame: 2 minutes after start of administration of trial medication
Occurrence of excellent intubating conditions 2 minutes after start of administration of 0.6 mg/kg rocuronium or 2 µg/kg remifentanil, scored according to Fuchs-Buder et al. The intubating conditions will be classified as excellent if all qualities are excellent, good if all qualities are either excellent or good and poor if the presence of a single quality is listed as poor.
3 secondary outcomes
Subjective side effects of laryngoscopy
Time frame: 24 hours postoperatively and 3 days postoperatively
Dose of ephedrine or dose of metaoxedrine administered
Time frame: From induction until the patient is ready to be positioned for surgery, ranging from 5 minutes up to 1 hour.
Intubating conditions according to IDS
Time frame: 2 minutes after start of administration of trial medication
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 22 Dec 2020.
- Derived from this study: PubMed 34310692Vested M, Sorensen AM, Bjerring C, Christensen RE, Dinesen F, Vang M, Gilvanoff A, Hansen TE, Nielsen T, Rasmussen LS. A blinded randomized study comparing intubating conditions after either rocuronium 0.6 mg.kg-1 or remifentanil 2 microg.kg-1 in elderly patients. Acta Anaesthesiol Scand. 2021 Nov;65(10):1367-1373. doi: 10.1111/aas.13957. Epub 2021 Sep 5.
- 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
Anne Marie Sørensen, MD, PhD principal investigator
Department of Neuroanaesthesia, Rigshospitalet, Glostrup, Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rocuronium 0.6 mg/kg and Remifentanil 2 µg/kg in people with Neuromuscular Blockade and Intubation Complication, run by Copenhagen University Hospital, Rigshospitalet at 2 sites 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 3 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 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Evaluation of intubating conditions ad modum Fuchs-Buder et al (time frame: 2 minutes after start of administration of trial medication). 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 NCT04287426, 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 22 Dec 2020.