Suxamethonium SensitivityCELOTOFNCT03415607
Comparison on Succinylcholine Onset Time Assessed by Train of Four Stimulation Versus Clinical Judgment During Rapid Sequence Induction of Anesthesia
An observational study of Suxamethonium Sensitivity and Aspiration of Gastric Contents Into Respiratory Tract, Part Unspecified, run by University Hospital, Caen at 1 site in France.
Trial summary
Succinylcholine is a myorelaxant agent often used during rapid sequence induction for patients who need to undergo general anesthesia but who are at risk of pulmonary aspiration of gastric content. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suxamethonium Sensitivity, Aspiration of Gastric Contents Into Respiratory Tract, Part Unspecified
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- 6 Nov 2017to Apr 2018
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Every patients undergoing general anesthesia with the use of suxamethonium for induction as assessed by the anesthesiologist
Who may be able to join
- Every patient undergoing general anesthesia with the use of suxamethonium for induction as assessed by the anesthesiologist
Who cannot join
- Patient under 18 years old
- Pregnant woman
- Nasotracheal intubation
- Monitoring of train of four at the adductor pollis impossible (such as patient with no arm )
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Caen
Caen, 14000
Clément Buléon, 33231063106, buleon-c@chu-caen.fr
Raphaël d'Orlando, 33231063106, dorlando-r@chu-caen.fr
About this study
Official title: Comparison on Succinylcholine Onset Time Assessed by Train of Four Stimulation Versus Clinical Judgment During Rapid Sequence Induction
Succinylcholine is a myorelaxant agent often used during rapid sequence induction for patients who need to undergo general anesthesia but who are at risk of pulmonary aspiration of gastric content. Whereas other myorelaxant agents are monitored with train of four stimulation to assess onset and duration, few anesthesiologists use train of four stimulation for onset of succinylcholine, as the anesthesiologists evaluate the effect with the time from injection (usually one minute) and the muscle fasciculation due to the release of acetylcholine.
The data available on onset duration of this drug are old and bases on only few studies, but the succinylcholine if sometime harmful (anaphylaxis , cardiac arrest, bronchospasm).
The investigators want to assess the onset time of succinylcholine with an objective toll , the train of four stimulation, and evaluate if the clinical judgment of the anesthesiologist is reliable to predict an adequate moment for endotracheal intubation.
- Conditions
- Suxamethonium Sensitivity, Aspiration of Gastric Contents Into Respiratory Tract, Part Unspecified
- Medical subject headings
- Butyrylcholinesterase deficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset of action of suxamethonium as assessed by the measurement of the train of four stimulation at the adductor pollis
Time, in seconds, between injection of suxamethonium and appearance of a value of zero on the train of four stimulation measurement (going to for on for to zero on for).
Measured: 60 seconds after the injection of suxamethonium
Time from suxamethonium injection to laryngoscopy
Time, in seconds, between the injection of suxamethonium and the laryngoscopy realized by the anesthesiologist.
Measured: 60 seconds after the injection of suxamethonium
Secondary outcomes (3)
Number of patients whom train of four was not 0 when they benefited from the laryngoscopy
Measured: 60 seconds after the injection of suxamethonium
Complications associated with use of suwamethnonium or early laryngoscopy
Measured: 60 seconds after the injection of suxamethonium
Main characteristics of the patients and intubation conditions
Measured: 60 seconds after the injection of suxamethonium
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start6 Nov 2017
- Primary completionApr 2018 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suxamethonium SensitivityStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clément Buléon, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03415607
- Sponsor's protocol ID
- CELOTOF
- Acronym
- CELOTOF
- Status last verified
- Nov 2017
- First submitted
- 16 Jan 2018
- Last updated
- 16 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison on Succinylcholine Onset Time Assessed by Train of Four Stimulation Versus Clinical Judgment During Rapid Sequence Induction
- ClinicalTrials.gov ID
- NCT03415607
- Acronym / sponsor ID
- CELOTOF / CELOTOF
- Conditions
- Suxamethonium Sensitivity, Aspiration of Gastric Contents Into Respiratory Tract, Part Unspecified
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 30 Jan 2018 (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.
Succinylcholine is a myorelaxant agent often used during rapid sequence induction for patients who need to undergo general anesthesia but who are at risk of pulmonary aspiration of gastric content. Whereas other myorelaxant agents are monitored with train of four stimulation to assess onset and duration, few anesthesiologists use train of four stimulation for onset of succinylcholine, as the anesthesiologists evaluate the effect with the time from injection (usually one minute) and the muscle fasciculation due to the release of acetylcholine.
The data available on onset duration of this drug are old and bases on only few studies, but the succinylcholine if sometime harmful (anaphylaxis , cardiac arrest, bronchospasm).
The investigators want to assess the onset time of succinylcholine with an objective toll , the train of four stimulation, and evaluate if the clinical judgment of the anesthesiologist is reliable to predict an adequate moment for endotracheal intubation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Every patients undergoing general anesthesia with the use of suxamethonium for induction as assessed by the anesthesiologist
Key inclusion criteria (1 listed)
- Every patient undergoing general anesthesia with the use of suxamethonium for induction as assessed by the anesthesiologist
Key exclusion criteria (4 listed)
- Patient under 18 years old
- Pregnant woman
- Nasotracheal intubation
- Monitoring of train of four at the adductor pollis impossible (such as patient with no arm )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Onset of action of suxamethonium as assessed by the measurement of the train of four stimulation at the adductor pollis
Time frame: 60 seconds after the injection of suxamethonium
Time, in seconds, between injection of suxamethonium and appearance of a value of zero on the train of four stimulation measurement (going to for on for to zero on for).
Time from suxamethonium injection to laryngoscopy
Time frame: 60 seconds after the injection of suxamethonium
Time, in seconds, between the injection of suxamethonium and the laryngoscopy realized by the anesthesiologist.
3 secondary outcomes
Number of patients whom train of four was not 0 when they benefited from the laryngoscopy
Time frame: 60 seconds after the injection of suxamethonium
Complications associated with use of suwamethnonium or early laryngoscopy
Time frame: 60 seconds after the injection of suxamethonium
Main characteristics of the patients and intubation conditions
Time frame: 60 seconds after the injection of suxamethonium
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2018.
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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.
Clément Buléon principal investigator
University Hospital, Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Suxamethonium Sensitivity and Aspiration of Gastric Contents Into Respiratory Tract, Part Unspecified, run by University Hospital, Caen at 1 site in France.
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 1 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: status not confirmed, as of the sponsor's last update on 16 Mar 2018. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clément Buléon, PH (33231063106, buleon-c@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Onset of action of suxamethonium as assessed by the measurement of the train of four stimulation at the adductor pollis (time frame: 60 seconds after the injection of suxamethonium). The study lists 2 primary outcomes in all. 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 16 Mar 2018.