Clinical trial NCT02983175: Ultrasound Assessment of Gastric Content Before Anesthesia for Appendectomy
Official title: Ultrasound Assessment of Gastric Content and Gastric Volume Before Crash Induction for Appendectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Appendectomy
Keywords: ultrasonogaphy
full stomach
pulmonary aspiration
anaesthesia
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2016-12-06
Enrollment: 150
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Performing anesthetic induction for appendicectomy has two main risks : first aspiraion of gastric content causing pneumonia. Otherwise, anaphylactic risk to drugs used during anesthetic induction. Indeed, the guidelines recommend an anesthetic induction protocol qualified "full stomach" whatever the patient and the preoperative fasting period are. This protocol provides the use of fast-acting neuromuscular blocking agents (succinylcholine or rocuronium). However, these neuromuscular blocking agents are ten times more at allergic risk than others. Ultrasound assessment of gastric content before rapid sequence induction of anesthesia is a reproducible, non-invasive, inexpensive and quickly achievable bedside technique. Furthermore, the correlations between gastric volume and risk of a full stomach and also between the cross-section antral area (CSA) and the risk of a full stomach have been validated on several patient cohorts. We formulate the hypothesis that the achievement of a gastric ultrasound before anesthetic induction for appendectomy could allow to identify "full stomach" patients who actually justify rapid sequence induction of anesthesia with exposure to fast-acting neuromuscular blocking agents that implies.

Primary endpoint is to determine te percentage of patients who have a gastric content before appendectomy. Secondary endpoint is to determine the incidenc of aspiration pneumonia and anaphylactic shock. Another secondary endpoint is to determine the percentage of patient with gastric content with the antral grading system (Perlas method) and to evaluate the concordance between this methode and the cross-section antral area.


Eligibility criteria: Inclusion Criteria:

* Patient admitted to the operating room for appendectomy.
* Major or minor patient (higher than 16) affiliated to a social security scheme.
* Patient or parents of minor patient who received the full information relative to the organization of the study and who signed his/their informed consent(s).

Exclusion Criteria:

* Pregnant women.
* Childbearing age patient does not have effective contraception.
* Breastfeeding woman.
* Minor patient under 16.
* Major patient subject to a measure of legal protection or unable to consent.
* Persons deprived of liberty by a judicial or an administrative decision.
* Patient with gastric and/or esophagus surgery history.

Primary outcomes:
measure: Cross-section antral area (CSA)
timeFrame: baseline J0
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Bouvet L, Mazoit JX, Chassard D, Allaouchiche B, Boselli E, Benhamou D. Clinical assessment of the ultrasonographic measurement of antral area for estimating preoperative gastric content and volume. Anesthesiology. 2011 May;114(5):1086-92. doi: 10.1097/ALN.0b013e31820dee48.
citation: Perlas A, Chan VW, Lupu CM, Mitsakakis N, Hanbidge A. Ultrasound assessment of gastric content and volume. Anesthesiology. 2009 Jul;111(1):82-9. doi: 10.1097/ALN.0b013e3181a97250.
citation: Reddy JI, Cooke PJ, van Schalkwyk JM, Hannam JA, Fitzharris P, Mitchell SJ. Anaphylaxis is more common with rocuronium and succinylcholine than with atracurium. Anesthesiology. 2015 Jan;122(1):39-45. doi: 10.1097/ALN.0000000000000512.