Anesthesia Clinical Trial
Official title:
Anesthesiological Management of Ventilation With Laryngeal Mask in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) and Endoscopic Ultrasound Procedures
Diagnostic and operative procedures of upper gastrointestinal (GI) tract are very common in
all patients. Some procedures are difficult to tolerate because of long duration, prone
position or significant stimulation of the upper airways. An example are endoscopic
retrograde cholangiopancreatography (ERCP) and endoscopic pancreatic ultrasound.
The procedures are generally performed with deep sedation. Many pharmacologic regimens are
available and described in literature. The investigator's institute adopts propofol target
controlled infusion (TCI), which usually guarantees unconsciousness and unresponsiveness of
patients. The main adverse event is dose-related respiratory depression. Pre-existing reasons
for hypoventilation can exacerbate this event, especially in the elderly and the chronic
obstructive pulmonary disease-patients. Laryngeal mask (LMA) is a useful tool to apply a
pressure support ventilation. One specific type of LMA allows to separate the gastric and
respiratory tract and, allows the anesthesiologist to support patient's ventilation as (and
only if) necessary.
This is a monocentric randomized controlled trial of superiority of LMA use in GI endoscopic
procedures. Randomization is centralized. The study is single blind (patient). The study is
no-profit. Every patients undergoing scheduled ERCP and endoscopic ultrasound will be
screened and consecutive eligible patients will be enrolled. Subjects will be allocated
according to a simple randomization list. The study starts after randomization and ends after
discharge from the recovery room. After peripheral venous catheter insertion and vital
parameters monitoring, patients will receive propofol TCI with a tailored target between 4
and 6 mcg/ml. The treatment group will receive LMA insertion and End-Tidal Carbon Dioxide
(ETCO2) monitoring throughout the procedure. In case of hypoventilation, with an ETCO2 above
50 mmHg, the patient will be supported as necessary with PSV. The control group will not
receive any airway device, according to the standard treatment. At the end of the procedure,
both group will receive a laboratory testing (peripheral arterial sample), when the patient
is still sedated. Vital parameters monitoring will continue in recovery room. Patients will
be discharge as usual with an Aldrete score > 9.
Data will be collected during the procedure and in recovery room. Data will be stored in
electronic database without mention to patient's name.
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