Rapid Sequence IntubationPhase 4NCT00953550
Rapid Sequence Intubation With Rocuronium-Sugammadex Compared With Succinylcholine
A Phase 4 study testing Rocuronium-Sugammadex and Succinylcholine in people with Rapid Sequence Intubation, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
Trial summary
Rapid sequence intubation is used, when there is an elevated risk of aspiration to the lungs of stomach content. It is typically used in acute settings that require acute surgery or in prehospital settings, but also in specific risk patients requiring elective surgery. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Rapid Sequence Intubation
- What is being tested?
- Rocuronium-Sugammadex and Succinylcholine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 2 sitesDenmark
- Study dates
- Sep 2009to Feb 2011
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Elective surgical patients with a planned rapid sequence induction of anaesthesia.
- Informed consent.
- Legally competent.
- Be able to understand Danish and be able to read the given information in Danish.
- Females can only participate if they have reached menopause, have had hysterectomy performed, use a coil as birthcontrol, or if they are sterilized.
Who cannot join
- Presence of kidney disease, defined as S-creatinine >0,200 mmol/L.
- Known lung or heart disease, defined as NYHA-class >2 or CCS-class >2.
- Known allergic reactions to Rocuronium, Suxamethon, Propofol or Sugammadex.
- Contraindications to Suxamethon. Including raised P-potassium (>5,0 mmol/L), untreated glaucoma, neuromuscular disorders or disposition to malignant hyperthermia.
- Body mass index of >35 kg/m2.
- Pregnant.
- Breastfeeding.
Trial locations and contacts
2 sites in 1 country.
About this study
Rapid sequence intubation is used, when there is an elevated risk of aspiration to the lungs of stomach content. It is typically used in acute settings that require acute surgery or in prehospital settings, but also in specific risk patients requiring elective surgery. The reason for conducting rapid sequence intubation is to minimize the risk of pulmonary aspiration and at the same time achieve a fast induction of anaesthesia and intubation. Rapid sequence intubation is a procedure with a high risk of complications in itself. The time period from induction of anaesthesia to intubation is particularly risky, because the patient is apneic. This study addresses this problem by investigating, how quickly spontaneous respiration can be reestablished after a rapid sequence intubation when using Rocuronium-Sugammadex compared to Succinylcholine. This is a pilot protocol that is intended to establish a sample size for the full protocol.
Study hypothesis: The time from correct tube placement to spontaneous respiration is shorter when using Rocuronium/Sugammadex compared to Succinylcholine.
- Conditions
- Rapid Sequence Intubation
- Being tested
- Rocuronium-Sugammadex, Succinylcholine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rocuronium-SugammadexDrug
Also called Esmeron, Bridion
Rocuronium 1,0 mg/kg is administered iv initially. Upon intubation Sugammadex is administered 16 mg/kg iv.
SuccinylcholineDrug
Also called Suxameton, Suxamethon
1 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Rocuronium-Sugammadex | Experimental | Not described Receives: Drug: Rocuronium-Sugammadex |
| Succinylcholine | Active comparator | Not described Receives: Drug: Succinylcholine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from verified correct tube placement after intubation to spontaneous respiration, defined as respiration frequency of >8/minute, tidal volume >3ml/kg and a saturation of >90% for 30 seconds.
Measured: 20 minutes
Secondary outcomes (7)
Duration of action. Measured as the time from administration of the neuromuscular blocking agent to the T1-value in Train-of-Four (TOF) returns to >90% of T1-max.
Measured: 20 minutes
Intubation Difficulty Scale (IDS)
Measured: 20 minutes
Intubation conditions
Measured: 20 minutes
Side effect - Muscle ache.
Measured: Postoperative (within 24 hours)
Side effect - Tachycardia (>100 beats per minute).
Measured: 20 minutes
Side effect - Bradycardia (<50 beats per minute).
Measured: 20 minutes
Side effect - Awareness/recall. Evaluated by modified Brice Questionaire.
Measured: Postoperative (within 24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionJan 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rapid Sequence IntubationStudies 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, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- TrygFonden, Denmark
- Investigators
- Martin K Sørensen, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00953550
- Sponsor's protocol ID
- 1B-RSI-SU
- Status last verified
- Dec 2010
- First submitted
- 5 Aug 2009
- Last updated
- 2 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Sequence Intubation With Rocuronium-Sugammadex Compared With Succinylcholine
- ClinicalTrials.gov ID
- NCT00953550
- Acronym / sponsor ID
- 1B-RSI-SU
- Conditions
- Rapid Sequence Intubation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- TrygFonden, Denmark
- Study start
- Sep 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 6 Aug 2009 (estimated)
- 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.
Rapid sequence intubation is used, when there is an elevated risk of aspiration to the lungs of stomach content. It is typically used in acute settings that require acute surgery or in prehospital settings, but also in specific risk patients requiring elective surgery. The reason for conducting rapid sequence intubation is to minimize the risk of pulmonary aspiration and at the same time achieve a fast induction of anaesthesia and intubation. Rapid sequence intubation is a procedure with a high risk of complications in itself. The time period from induction of anaesthesia to intubation is particularly risky, because the patient is apneic. This study addresses this problem by investigating, how quickly spontaneous respiration can be reestablished after a rapid sequence intubation when using Rocuronium-Sugammadex compared to Succinylcholine. This is a pilot protocol that is intended to establish a sample size for the full protocol.
Study hypothesis: The time from correct tube placement to spontaneous respiration is shorter when using Rocuronium/Sugammadex compared to Succinylcholine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rocuronium-Sugammadex | Experimental | Drug: Rocuronium-Sugammadex |
| Succinylcholine | Active comparator | Drug: Succinylcholine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Elective surgical patients with a planned rapid sequence induction of anaesthesia.
- Informed consent.
- Legally competent.
- Be able to understand Danish and be able to read the given information in Danish.
- Females can only participate if they have reached menopause, have had hysterectomy performed, use a coil as birthcontrol, or if they are sterilized.
Key exclusion criteria (7 listed)
- Presence of kidney disease, defined as S-creatinine >0,200 mmol/L.
- Known lung or heart disease, defined as NYHA-class >2 or CCS-class >2.
- Known allergic reactions to Rocuronium, Suxamethon, Propofol or Sugammadex.
- Contraindications to Suxamethon. Including raised P-potassium (>5,0 mmol/L), untreated glaucoma, neuromuscular disorders or disposition to malignant hyperthermia.
- Body mass index of >35 kg/m2.
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-SugammadexAlso: Esmeron, BridionRocuronium 1,0 mg/kg is administered iv initially. Upon intubation Sugammadex is administered 16 mg/kg iv. | Drug | Rocuronium-Sugammadex |
| SuccinylcholineAlso: Suxameton, Suxamethon1 mg/kg | Drug | Succinylcholine |
Primary outcome
Time from verified correct tube placement after intubation to spontaneous respiration, defined as respiration frequency of >8/minute, tidal volume >3ml/kg and a saturation of >90% for 30 seconds.
Time frame: 20 minutes
7 secondary outcomes
Duration of action. Measured as the time from administration of the neuromuscular blocking agent to the T1-value in Train-of-Four (TOF) returns to >90% of T1-max.
Time frame: 20 minutes
Intubation Difficulty Scale (IDS)
Time frame: 20 minutes
Intubation conditions
Time frame: 20 minutes
Side effect - Muscle ache.
Time frame: Postoperative (within 24 hours)
Side effect - Tachycardia (>100 beats per minute).
Time frame: 20 minutes
Side effect - Bradycardia (<50 beats per minute).
Time frame: 20 minutes
Side effect - Awareness/recall. Evaluated by modified Brice Questionaire.
Time frame: Postoperative (within 24 hours)
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 2 Mar 2011.
Related trials for Rapid Sequence Intubation
Not yet recruitingPhase 4
Propofol or Esketamine: Tracheal Intubation Comparison
Critically Ill Adults Requiring Emergency Tracheal Intubation in the Intensive Care Unit
Recruiting
Delayed Against Rapid Sequence Induction in Adults With Medical Diseases Undergoing Emergency Endotracheal Intubation.
Intubation in Intensive Care Units
Enrolling by invitationObservational study
Effect of Ketamine and Etomidate During RSI on Long Term Outcomes
Post-Traumatic Stress Disorder, Acute Respiratory Failure
RecruitingObservational study
Assessment of Hemodynamic Responses at Adequate Depth of Anesthesia Using Bispectral Index During Rapid Sequence Intubation in the Emergency Department
Critical Illness
Not yet recruiting
Comparison of High-Flow Nasal Cannula and Tight Face Mask for Maintaining Oxygenation During Rapid Sequence Induction
Hypoxemia, Airway Management
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.
Martin K Sørensen, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
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-Sugammadex and Succinylcholine in people with Rapid Sequence Intubation, 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 7 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 2 Mar 2011. 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?
Time from verified correct tube placement after intubation to spontaneous respiration, defined as respiration frequency of >8/minute, tidal volume >3ml/kg and a saturation of >90% for 30 seconds. (time frame: 20 minutes). 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 2 Mar 2011.