IntubationPhase 4NCT00355368
Succinylcholine Versus Rocuronium for Emergency Intubation in Intensive Care
A Phase 4 study testing Succinylcholine and Rocuronium in people with Intubation, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Emergency intubation of patients in intensive care is a high-risk endeavour. For many decades, succinylcholine has been the neuromuscular blocking agent of choice. However, succinylcholine may have life-threatening side effects and is contraindicated in a variety of diseases relevant in intensive care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation
- What is being tested?
- Succinylcholine and Rocuronium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2006to Jul 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- indication for emergency intubation in intensive care
- availability of qualified study physician
Who cannot join
- contraindication against succinylcholine or rocuronium
- indication for awake fibreoptic intubation
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Medical Intensive Care; University of Basel
Basel, Canton of Basel-City, 4031
About this study
Official title: Phase 4 Study of Succinylcholine Versus Rocuronium as Neuromuscular Blocking Agent for Emergency Intubation in Intensive Care
Emergency intubation of patients in intensive care is a high-risk endeavour. For many decades, succinylcholine has been the neuromuscular blocking agent of choice. However, succinylcholine may have life-threatening side effects and is contraindicated in a variety of diseases relevant in intensive care. The nondepolarizing agent rocuronium has been propagated as alternative for succinylcholine. Though a recent meta-analysis found no difference in intubating conditions between succinylcholine and rocuronium in elective cases, there are no data in emergent cases in intensive care. The aim of the present study is to compare succinylcholine and rocuronium with regard to 1) quality of intubating conditions, 2) length of the intubating sequence, 3) failed intubating attempts, 4) hemodynamic sequelae of intubation, and 5) desaturations.
Read the detailed description
Objective: to compare succinylcholine and rocuronium with regard to 1) quality of intubating conditions, 2) length of the intubating sequence, 3) failed intubating attempts, 4) hemodynamic sequelae of intubation, and 5) desaturations.
Design: prospective, randomized, single-blind study. Setting: Intensive care units of an University Hospital. Patients: adult patients in intensive care requiring emergency intubation. Randomization: 1:1 randomization to either succinylcholine (1mg/kg) or rocuronium (0.6 mg/kg).
Data: 1) assessment of the quality of intubating conditions by means of a score, 2) length of the intubating sequence defined as time between injection of neuromuscular blocking agent and first end-tidal CO2 on the monitor, 3) number of failed intubating attempts, 4) hemodynamic sequelae of intubation, defined as events requiring injection of vasoactive drugs, and 5) desaturations, defined as saturation below 90% and/or any decrease in saturation of 5% or more.
- Conditions
- Intubation
- Being tested
- Succinylcholine, Rocuronium
- Keywords
- intubation, intensive care, neuromuscular depolarizing agents, neuromuscular nondepolarizing agents, neuromuscular blocking agents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuccinylcholineDrug
1mg/kg iv
RocuroniumDrug
0.6mg/kg iv
| Study group | Role | What they receive |
|---|---|---|
| Succinylcholine | Active comparator | Not described Receives: Drug: Succinylcholine |
| Rocuronium | Active comparator | Not described Receives: Drug: Rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Exhibiting Desaturation >5%
decrease of >5% in oxygen saturation measured continuously using pulse oxymetry
Measured: at any time between the start of the intubation sequence and 2min after the completion of intubation
Secondary outcomes (4)
Haemodynamic Sequelae of Intubation
any new haemodynamic alteration requiring immediate intervention
Measured: between start of induction sequence and 5 min after completion of intubation
Time to Completion of Intubation
time interval between the injection of the induction agent and the first appearance of endtidal CO2
Measured: time interval between the injection of the induction agent and the first appearance of endtidal CO2
Quality of Intubation Conditions Using a Validated Score: Viby-Mogensen et al. Good Clinical Research Practice (GCRP) in Pharmacodynamic Studies of Neuromuscular Blocking Agents. Acta Anaesthesiol Scand 1996;40:59-74.
The factors laryngoscopy, vocal cords, and response to intubation are individually rated with a score from 1 (bad intubation conditions)to 3 (excellent intubation conditions)and the resulting three scores are summed up. The maximum score is thus 9 while the minimum score is 3.
Units: measure on a scale
Measured: during laryngoscopy and the first minute after completion of intubation
Number of Participants With an Failed First Intubation Attempts
defined as either uncompleted intubation attempt within 90 sec or starting a second intubation attempt
Measured: within the first 90 sec following the start of induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2006 (estimated)
- Study startAug 2006
- Primary completionAug 2006
- Study completionJul 2010
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 IntubationStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephan Marsch, University Hospital, Basel, Switzerland
- Investigators
- Martin Siegemund, MD, Principal investigator, Department of Surgical Intensive Care, University of BaselStephan C Marsch, MD, DPhil, Principal investigator, Department of Medical Intensive Care, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00355368
- Sponsor's protocol ID
- EK 145/05
- Status last verified
- Nov 2011
- First submitted
- 20 Jul 2006
- Last updated
- 15 Dec 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Sluga M, Ummenhofer W, Studer W, Siegemund M, Marsch SC. Rocuronium versus succinylcholine for rapid sequence induction of anesthesia and endotracheal intubation: a prospective, randomized trial in emergent cases. Anesth Analg. 2005 Nov;101(5):1356-1361. doi: 10.1213/01.ANE.0000180196.58567.FE.
PubMed 16243994Marsch SC, Steiner L, Bucher E, Pargger H, Schumann M, Aebi T, Hunziker PR, Siegemund M. Succinylcholine versus rocuronium for rapid sequence intubation in intensive care: a prospective, randomized controlled trial. Crit Care. 2011 Aug 16;15(4):R199. doi: 10.1186/cc10367.
PubMed 21846380
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Succinylcholine Versus Rocuronium as Neuromuscular Blocking Agent for Emergency Intubation in Intensive Care
- ClinicalTrials.gov ID
- NCT00355368
- Acronym / sponsor ID
- EK 145/05
- Conditions
- Intubation
- Keywords
- intubation, intensive care, neuromuscular depolarizing agents, neuromuscular nondepolarizing agents, neuromuscular blocking agents
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Aug 2006 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 21 Jul 2006 (estimated)
- Results
- Posted 15 Dec 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Emergency intubation of patients in intensive care is a high-risk endeavour. For many decades, succinylcholine has been the neuromuscular blocking agent of choice. However, succinylcholine may have life-threatening side effects and is contraindicated in a variety of diseases relevant in intensive care. The nondepolarizing agent rocuronium has been propagated as alternative for succinylcholine. Though a recent meta-analysis found no difference in intubating conditions between succinylcholine and rocuronium in elective cases, there are no data in emergent cases in intensive care. The aim of the present study is to compare succinylcholine and rocuronium with regard to 1) quality of intubating conditions, 2) length of the intubating sequence, 3) failed intubating attempts, 4) hemodynamic sequelae of intubation, and 5) desaturations.
Detailed description
Objective: to compare succinylcholine and rocuronium with regard to 1) quality of intubating conditions, 2) length of the intubating sequence, 3) failed intubating attempts, 4) hemodynamic sequelae of intubation, and 5) desaturations.
Design: prospective, randomized, single-blind study. Setting: Intensive care units of an University Hospital. Patients: adult patients in intensive care requiring emergency intubation. Randomization: 1:1 randomization to either succinylcholine (1mg/kg) or rocuronium (0.6 mg/kg).
Data: 1) assessment of the quality of intubating conditions by means of a score, 2) length of the intubating sequence defined as time between injection of neuromuscular blocking agent and first end-tidal CO2 on the monitor, 3) number of failed intubating attempts, 4) hemodynamic sequelae of intubation, defined as events requiring injection of vasoactive drugs, and 5) desaturations, defined as saturation below 90% and/or any decrease in saturation of 5% or more.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Succinylcholine | Active comparator | Drug: Succinylcholine |
| Rocuronium | Active comparator | Drug: Rocuronium |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- indication for emergency intubation in intensive care
- availability of qualified study physician
Key exclusion criteria (2 listed)
- contraindication against succinylcholine or rocuronium
- indication for awake fibreoptic intubation
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 |
|---|---|---|
| Succinylcholine1mg/kg iv | Drug | Succinylcholine |
| Rocuronium0.6mg/kg iv | Drug | Rocuronium |
Primary outcome
Number of Participants Exhibiting Desaturation >5%
Time frame: at any time between the start of the intubation sequence and 2min after the completion of intubation
decrease of >5% in oxygen saturation measured continuously using pulse oxymetry
4 secondary outcomes
Haemodynamic Sequelae of Intubation
Time frame: between start of induction sequence and 5 min after completion of intubation
Time to Completion of Intubation
Time frame: time interval between the injection of the induction agent and the first appearance of endtidal CO2
Quality of Intubation Conditions Using a Validated Score: Viby-Mogensen et al. Good Clinical Research Practice (GCRP) in Pharmacodynamic Studies of Neuromuscular Blocking Agents. Acta Anaesthesiol Scand 1996;40:59-74.
Time frame: during laryngoscopy and the first minute after completion of intubation
Number of Participants With an Failed First Intubation Attempts
Time frame: within the first 90 sec following the start of induction
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16243994Sluga M, Ummenhofer W, Studer W, Siegemund M, Marsch SC. Rocuronium versus succinylcholine for rapid sequence induction of anesthesia and endotracheal intubation: a prospective, randomized trial in emergent cases. Anesth Analg. 2005 Nov;101(5):1356-1361. doi: 10.1213/01.ANE.0000180196.58567.FE.
- Derived from this study: PubMed 21846380Marsch SC, Steiner L, Bucher E, Pargger H, Schumann M, Aebi T, Hunziker PR, Siegemund M. Succinylcholine versus rocuronium for rapid sequence intubation in intensive care: a prospective, randomized controlled trial. Crit Care. 2011 Aug 16;15(4):R199. doi: 10.1186/cc10367.
Related trials for Intubation
Not yet recruitingObservational study
AI-assisted Tracheal Intubation in Children
Intubation
Not yet recruiting
AI Smart Glasses Feedback for Intubation Training in Medical Students
Intubation, Intratracheal, Medical Education
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Recruiting
Vagal Stimulator to Reduce Nasogastric Tube Use
Nasogastric Tube Intubation
Enrolling by invitation
Pediatric Intubation Simulations With Bougie
Difficult Airway Intubation
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 Siegemund, MD principal investigator
Department of Surgical Intensive Care, University of Basel
Stephan C Marsch, MD, DPhil principal investigator
Department of Medical Intensive Care, University of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Succinylcholine and Rocuronium in people with Intubation, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 2 inclusion and 2 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 15 Dec 2011. 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 Switzerland. 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?
Yes. Results are posted in the registry (first posted 15 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Exhibiting Desaturation >5% (time frame: at any time between the start of the intubation sequence and 2min after the completion of intubation). 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 NCT00355368, which also lists 2 linked publications.
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 15 Dec 2011.