Propofol Administered by Gastroenterologists by Target Controlled Infusion Pump During Endoscopy

Study Overview
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Brief Summary
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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.

Official Title
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Propofol Administered by Gastroenterologists by Target Controlled Infusion Pump During Endoscopy: a Randomized Double Blind Controlled Study

Conditions
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Sedation, Endoscopy

Intervention / Treatment
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* Drug: Propofol
* Drug: Midazolam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age < 18 years American Society of Anesthesiologists risk I-II patients undergoing to Gastroscopy or Colonoscopy Exclusion Criteria: significant systemic disease allergic reactions to any of study drugs chronic use of opioids or psychiatric disorders pregnancy Mallampati score > 2 age < 18 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: propofol group<br>70 patients (35 upper endoscopy - 35 colonoscopy) | Drug: Propofol<br>* 70 patients (35 upper endoscopy - 35 colonoscopy) are sedated with propofol TCI (Target Controlled Infusion) pump (concentration 1.2-1.6 mcg/ml).<br>|
| Active Comparator: midazolam group<br>70 patients (35 upper endoscopy - 35 colonoscopy) | Drug: Midazolam<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | 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) | at 24-72 hours after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | one day | 
| Number of Participants With Adverse Events as a Measure of Safety | Number of patients with adverse events (hypotension, bradycardia, hypoxemia,...) | one day |