Propofol TCI Administered by Gastroenterologists During Endoscopy: a Randomized Double Blind Controlled Study

Study Overview
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Brief Summary
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Many studies address safety and effectiveness of non-anesthesiologist propofol sedation (NAPS) for GI endoscopy. Target Controlled Infusion (TCI) is a sophisticated tool for providing optimal sedation regimen and avoiding under or oversedation. This randomized double blind controlled study compares standard moderate sedation level of sedation (group S) during upper endoscopy (EGD) and colonoscopy (CS) versus propofol NAPS (group P).

Detailed Description
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70 CS and 70 EGD ASA I-II patients were studied. In group S (n=70) we administered fentanyl (1μg/kg) + midazolam (0.04-0.03 mg/kg) for CS and midazolam (0.04-0.03 mg/kg) for EGDS and in group P (n=70) fentanyl 1µg/Kg + propofol TCI 1.2-1.6 μg/ml for CS and propofol TCI 1.2-1.6 μg/ml for EGD. Vital parameters and Observer's Assessment of Alertness and Sedation Scale (OAA/S) were monitored throughout the study. Endoscopist's and patient's satisfactions were measured after procedure and 24-72 h later by visual analog scale (VAS).

Official Title
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Phase IV Study of Propofol TCI (Target Controlled Infusion)Administered by Gastroenterologists During Endoscopy in Moderate Sedation: a Randomized Double Blind Controlled Study

Conditions
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Propofol, Target Controlled Infusion, Moderate Sedation, Gastrointestinal Endoscopy

Intervention / Treatment
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* Drug: Propofol
* Drug: Midazolam
* Device: Target Controlled Infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age >18 yrs ASA (American Society of Anesthesiologists risk class III-IV)I-II patients undergoing to gastroscopy or colonoscopy Exclusion Criteria: significant systemic disease (American Society of Anesthesiologists risk class III-IV) history of allergic reactions to any of the study drugs chronic use of opioid analgesics psychiatric disorder pregnancy difficult airways (Mallampati score >2) age <18 yrs

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<br>Patients in Group Propofol(n=70) were seated with propofol target concentration 1.2-1.6 µg/ml. Patients in both groups undergoing CS received also iv fentanyl (1μg/Kg) for pain control. | Drug: Propofol<br> <br> Device: Target Controlled Infusion<br> <br> |
| Active Comparator: midazolam<br>Control Group: patients in Group midazolam (n=70) were sedated with midazolam 0.04 mg/kg if aged< 70 - 0.03 mg/kg if aged> 70. Patients in both groups undergoing CS received also iv fentanyl (1μg/Kg) for pain control. | Drug: Midazolam<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopist's VAS (Visual Analog Scale) satisfaction about propofol TCI moderate sedation | Endoscopist's satisfaction was measured after endoscopic procedures by visual analog scale (VAS 0-100). | one day | 
| Patient's VAS (Visual Analog Scale) satisfactions about propofol TCI moderate sedation | Patient's satisfactions were measured after endoscopic procedures and 24-48 hours later by visual analog scale (VAS 0-100). | one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (number of partecipants with adverse events) of propofol TCI moderate sedation | To compare safety (number of partecipants with adverse events) of propofol TCI versus midazolam iv boluses during upper endoscopy (EGD) and colonoscopy (CS). Both sedation regimens were administered by endoscopists. | one day | 
| Time to dischargeability (minutes to reach Modified Aldrete score ≥ 18) of patients | To compare time to dischargeability (minutes to reach Modified Aldrete score ≥ 18) of patients in group standard versus propofol TCI group safety (number of partecipants with adverse events) of propofol TCI versus midazolam iv boluses during upper endoscopy (EGD) and colonoscopy (CS). Both sedation regimens were administered by endoscopists. | one day |