Many studies address safety of non-anesthesiologist propofol sedation (NAPS) for gastrointestinal endoscopy. Target Controlled Infusion (TCI) is a sophisticated tool for providing optimal sedation regimen and avoiding under or oversedation. The objective of the study is to compare standard moderate sedation during upper endoscopy and colonoscopy versus propofol NAPS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
140
70 patients (35 upper endoscopy - 35 colonoscopy) are sedated with propofol TCI (Target Controlled Infusion) pump (concentration 1.2-1.6 mcg/ml).
70 patients (35 upper endoscopy - 35 colonoscopy) in group midazolam are sedated with midazolam 0.04 mg/Kg if aged \< 70, 0.03 mg/Kg if aged \> 70.
San Raffaele Hospital
Milan, Italy, Italy
Endoscopist's Satisfaction (Visual Analog Scale) About Sedation
Visual Analog Scale from 0 to100 (0=dissatisfaction - 100=complete satisfaction) will be used to assess the technical difficulty of examination and the satisfaction with sedation of patient experienced by endoscopist
Time frame: at the end of the exam
Patient's Satisfaction (Visual Analog Scale) About Sedation Before Discharge
When completely awake, patients will be asked to rate the degree of pain/discomfort and the degree of satisfaction about quality of sedation from 0 to100 (0=dissatisfaction - 100=complete satisfaction)
Time frame: before discharge
Patient's Satisfaction (Visual Analog Scale) About Sedation 24-72 Hours After Procedure
Patients will be contacted by telephone 24-72 hours after discharge and asked about their satisfaction about the quality of sedation, rated on a verbal rating scale, from 0 to 100 (0=dissatisfaction; 100=complete satisfaction)
Time frame: at 24-72 hours after procedure
Time (Minutes) to Dischargeability of Patient From Endoscopic Unit
After endoscopy, patients will be transferred to recovery area and evaluated every 5 minutes until they will be ready to be discharged from the Endoscopy Unit. Recovery will be assessed using the Modified Aldrete Scoring System; patients will be considered fit for discharge with a Modified Aldrete Scoring System score of 18 or more, stable vital signs and without nausea, vomiting, or itching.
Time frame: one day
Number of Participants With Adverse Events as a Measure of Safety
Number of patients with adverse events (hypotension, bradycardia, hypoxemia,...)
Time frame: one day
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