Intubation ConditionsPhase 4NCT04868409
Intubating Conditions During Rapid Sequence Induction in Elderly With Either Suxamethonium 1.0 mg/kg or Rocuronium 1.0 mg/kg
A Phase 4 study testing Suxamethonium and Rocuronium in people with Intubation Conditions, run by Matias Vested at 4 sites in Denmark.
Trial summary
The aim of this study is to determine the proportion of excellent tracheal intubation conditions at 60 seconds after administration of either rocuronium 1.0 mg/kg or suxamethonium 1 mg/kg in patients with age ≥ 80 years during rapid sequence induction. Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Intubation Conditions
- What is being tested?
- Suxamethonium and Rocuronium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 4 sitesDenmark
- Study dates
- 12 Aug 2021to 17 Mar 2024
- 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 surgery under general anesthesia with indication for rapid sequence induction
- American Society of Anesthesiologists physical status classification (ASA) I to IV
- Informed consent (see appendix 1)
- Body mass index (BMI) < 35 kg/m2
- Read and understand Danish
Who cannot join
- Neuromuscular disease
- Known allergy to rocuronium and/or suxamethonium
- Known hyperkalemia > 5 mM
- Previous malignant hyperthermia
- Known homozygote plasmacholinesterase gene mutation variant a or s
- Known impaired kidney function defined as estimated glomerular filtration rate (eGFR) < 30
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites
Rigshospitalet
Copenhagen, 2830
Bispebjerg Hospital
Copenhagen
Department of Anaesthesiology, Pain and Respiratory Support, Rigshospitalet Glostrup
Glostrup Municipality
Holbæk Hospital
Holbæk
About this study
Official title: A Single Blinded Multicenter Randomized Study Comparing Intubating Conditions During Rapid Sequence Induction With Either Suxamethonium 1.0 mg/kg or Rocuronium 1.0 mg/kg in Elderly Patients (≥ 80 Years Old)
The aim of this study is to determine the proportion of excellent tracheal intubation conditions at 60 seconds after administration of either rocuronium 1.0 mg/kg or suxamethonium 1 mg/kg in patients with age ≥ 80 years during rapid sequence induction.
Read the detailed description
Elderly patients are frail and susceptible to complications in the perioperative period. They 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).
The number of elderly patients (>80 years) is increasing and a large proportion of these patients will require surgery and anesthesia with employment of rapid sequence induction (RSI) within the next decades. RSI and intubation is performed when there is an increased risk of pulmonary aspiration of gastric contents. Because of its fast onset time succinylcholine is often used to facilitate tracheal intubation during RSI. However, succinylcholine has certain side effects such as cardiac arrhythmia, hyperkalemia, muscle soreness, short duration of action and shorter time to desaturation.
It is therefore unknown if succinylcholine 1.0 mg/kg provides better intubating conditions compared to high dose rocuronium (1.0 mg/kg) in the elderly. In this matter, there remains a need for a study to investigate the optimal muscle relaxant during rapid sequence induction for facilitating tracheal intubation in the elderly.
- Conditions
- Intubation Conditions
- Being tested
- Suxamethonium, Rocuronium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuxamethoniumDrug
Also called Succinylcholine
1 mg/kg for tracheal intubation after 60 seconds
RocuroniumDrug
Also called Esmeron
1 mg/kg for tracheal intubation after 60 seconds
| Study group | Role | What they receive |
|---|---|---|
| Rocuronium group | Active comparator | Rocuronium 1 mg/kg Receives: Drug: Rocuronium |
| Suxamethonium group | Active comparator | Suxamethonium 1 mg/kg Receives: Drug: Suxamethonium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation conditions
Tracheal intubating conditions according to the Fuchs-Buder scale: Excellent, good or poor depending on laryngoscopy, vocal chords and reaction to intubation,
Measured: 60 seconds after induction of anaesthesia
Secondary outcomes (8)
Time to tracheal intubation
- Time to tracheal intubation (from administration of muscle relaxant till correct placement of tracheal tube)
Measured: within 15 minutes after administration of muscle relaxant
Time to TOF count 0
Time till no response from the nerve-stimulator after administration of muscle relaxant
Measured: within 15 minutes
First pas succes rate
Succes of tracheal tube placement 60 seconds after administration of muscle relaxant
Measured: within 15 minutes
Intubation conditions
Intubation conditions evaluated on the Intubation Difficulty Scale ranging from 0 (best) til 10 (worst)
Measured: within 15 minutes
Desaturation
spO2 < 0.9
Measured: within 15 minutes
cardiac arrythmia
Occurrence of new cardiac arrythmia during induction of anaesthesia (<15 minutes from administration of muscle relaxant)
Measured: within 15 minutes of anesthesia
sore throat
blinded assessment of sore throat reported by the patient on a numerical ranking scale (0 best, 10 worst)
Measured: 24 hours after anaesthesia
muscle soreness
blinded assessment of muscle soreness reported by the patient on a numerical ranking scale (0 best, 10 worst)
Measured: 24 hours after anaesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start12 Aug 2021
- Primary completion14 Mar 2024
- Study completion17 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation ConditionsStudies of the same condition, open and under way.
- 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
- Model description
- Randomized study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Matias Vested
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Matias Vested, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Lars S Rasmussen, Study chair, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04868409
- Sponsor's protocol ID
- H-20074958
- Status last verified
- Mar 2024
- First submitted
- 22 Apr 2021
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Blinded Multicenter Randomized Study Comparing Intubating Conditions During Rapid Sequence Induction With Either Suxamethonium 1.0 mg/kg or Rocuronium 1.0 mg/kg in Elderly Patients (≥ 80 Years Old)
- ClinicalTrials.gov ID
- NCT04868409
- Acronym / sponsor ID
- H-20074958
- Conditions
- Intubation Conditions
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Matias VestedUniversity, hospital or other
- Study start
- 12 Aug 2021 (actual)
- Primary completion
- 14 Mar 2024 (actual)
- Study completion
- 17 Mar 2024 (actual)
- First posted
- 3 May 2021 (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 aim of this study is to determine the proportion of excellent tracheal intubation conditions at 60 seconds after administration of either rocuronium 1.0 mg/kg or suxamethonium 1 mg/kg in patients with age ≥ 80 years during rapid sequence induction.
Detailed description
Elderly patients are frail and susceptible to complications in the perioperative period. They 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).
The number of elderly patients (>80 years) is increasing and a large proportion of these patients will require surgery and anesthesia with employment of rapid sequence induction (RSI) within the next decades. RSI and intubation is performed when there is an increased risk of pulmonary aspiration of gastric contents. Because of its fast onset time succinylcholine is often used to facilitate tracheal intubation during RSI. However, succinylcholine has certain side effects such as cardiac arrhythmia, hyperkalemia, muscle soreness, short duration of action and shorter time to desaturation.
It is therefore unknown if succinylcholine 1.0 mg/kg provides better intubating conditions compared to high dose rocuronium (1.0 mg/kg) in the elderly. In this matter, there remains a need for a study to investigate the optimal muscle relaxant during rapid sequence induction for facilitating tracheal intubation in the elderly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized study
| Arm | Type | Receives |
|---|---|---|
| Rocuronium group | Active comparator | Drug: RocuroniumRocuronium 1 mg/kg |
| Suxamethonium group | Active comparator | Drug: SuxamethoniumSuxamethonium 1 mg/kg |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Age ≥ 80
- Scheduled for surgery under general anesthesia with indication for rapid sequence induction
- American Society of Anesthesiologists physical status classification (ASA) I to IV
- Informed consent (see appendix 1)
- Body mass index (BMI) < 35 kg/m2
Key exclusion criteria (6 listed)
- Neuromuscular disease
- Known allergy to rocuronium and/or suxamethonium
- Known hyperkalemia > 5 mM
- Previous malignant hyperthermia
- Known homozygote plasmacholinesterase gene mutation variant a or s
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 |
|---|---|---|
| SuxamethoniumAlso: Succinylcholine1 mg/kg for tracheal intubation after 60 seconds | Drug | Suxamethonium group |
| RocuroniumAlso: Esmeron1 mg/kg for tracheal intubation after 60 seconds | Drug | Rocuronium group |
Primary outcome
Intubation conditions
Time frame: 60 seconds after induction of anaesthesia
Tracheal intubating conditions according to the Fuchs-Buder scale: Excellent, good or poor depending on laryngoscopy, vocal chords and reaction to intubation,
8 secondary outcomes
Time to tracheal intubation
Time frame: within 15 minutes after administration of muscle relaxant
Time to TOF count 0
Time frame: within 15 minutes
First pas succes rate
Time frame: within 15 minutes
Intubation conditions
Time frame: within 15 minutes
Desaturation
Time frame: within 15 minutes
cardiac arrythmia
Time frame: within 15 minutes of anesthesia
sore throat
Time frame: 24 hours after anaesthesia
muscle soreness
Time frame: 24 hours after anaesthesia
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 19 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Intubation Conditions
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Comparative Efficacy and Safety of Propofol-Ketamine Combination Versus Propofol Monotherapy in Geriatric Patients Under Invasive Ventilation
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The ED-AWARENESS-2 Trial
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Not yet recruitingObservational study
Modified El-Ganzouri Risk Index for Predicting Difficult Intubation in Obese Patients
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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.
Lars S Rasmussen study chair
Copenhagen University Hospital, Rigshospitalet
4 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 Suxamethonium and Rocuronium in people with Intubation Conditions, run by Matias Vested at 4 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 6 inclusion and 6 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 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Intubation conditions (time frame: 60 seconds after induction of anaesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Mar 2024.