Comparison on Succinylcholine Onset Time Assessed by Train of Four Stimulation Versus Clinical Judgment During Rapid Sequence Induction of Anesthesia (CELOTOF)

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.

Study Overview

• Status: Unknown
• Conditions: Suxamethonium Sensitivity; Aspiration of Gastric Contents Into Respiratory Tract, Part Unspecified

• Study Type: Observational
• Enrollment (Anticipated): 110

Contacts and Locations

• Study Contact: Name: Clément Buléon, PH; Phone Number: 33231063106; Email: buleon-c@chu-caen.fr
• Study Contact Backup: Name: Raphaël d'Orlando; Phone Number: 33231063106; Email: dorlando-r@chu-caen.fr

Study Locations

• France
  • Caen, France, 14000
    • Recruiting
    • CHU Caen
    • Contact: Raphaël d'Orlando; Phone Number: 33231063106; Email: dorlando-r@chu-caen.fr
    • Contact: Clément Buléon; Phone Number: 33231063106; Email: buleon-c@chu-caen.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Time Frame
Number of patients whom train of four was not 0 when they benefited from the laryngoscopy	60 seconds after the injection of suxamethonium
Complications associated with use of suwamethnonium or early laryngoscopy	60 seconds after the injection of suxamethonium
Main characteristics of the patients and intubation conditions	60 seconds after the injection of suxamethonium

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Investigators: Principal Investigator: Clément Buléon, University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2017
• Primary Completion (Anticipated): April 1, 2018
• Study Completion (Anticipated): April 1, 2018

Study Registration Dates

• First Submitted: January 16, 2018
• First Submitted That Met QC Criteria: January 23, 2018
• First Posted (Actual): January 30, 2018

Study Record Updates

• Last Update Posted (Actual): March 16, 2018
• Last Update Submitted That Met QC Criteria: March 15, 2018
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: CELOTOF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No