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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03415607
Other study ID # CELOTOF
Secondary ID
Status Recruiting
Phase N/A
First received January 16, 2018
Last updated March 15, 2018
Start date November 6, 2017
Est. completion date April 2018

Study information

Verified date November 2017
Source University Hospital, Caen
Contact Clément Buléon, PH
Phone 33231063106
Email buleon-c@chu-caen.fr
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 110
Est. completion date April 2018
Est. primary completion date April 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Every patient undergoing general anesthesia with the use of suxamethonium for induction as assessed by the anesthesiologist

Exclusion Criteria:

- 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 )

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France CHU Caen Caen

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 60 seconds after the injection of suxamethonium
Primary Time from suxamethonium injection to laryngoscopy Time, in seconds, between the injection of suxamethonium and the laryngoscopy realized by the anesthesiologist. 60 seconds after the injection of suxamethonium
Secondary Number of patients whom train of four was not 0 when they benefited from the laryngoscopy 60 seconds after the injection of suxamethonium
Secondary Complications associated with use of suwamethnonium or early laryngoscopy 60 seconds after the injection of suxamethonium
Secondary Main characteristics of the patients and intubation conditions 60 seconds after the injection of suxamethonium