Phase IV Study of Propofol TCI (Target Controlled Infusion)Administered by Gastroenterologists During Endoscopy in Moderate Sedation: a Randomized Double Blind Controlled Study
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Endoscopist's VAS (Visual Analog Scale) satisfaction about propofol TCI moderate sedation
Study Overview
Brief Summary
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
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
propofol
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.
Intervention: Propofol (Drug)
propofol
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.
Intervention: Target Controlled Infusion (Device)
midazolam
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.
Intervention: Midazolam (Drug)
Outcomes
Primary Outcomes
Endoscopist's VAS (Visual Analog Scale) satisfaction about propofol TCI moderate sedation
Time Frame: one day
Endoscopist's satisfaction was measured after endoscopic procedures by visual analog scale (VAS 0-100).
Patient's VAS (Visual Analog Scale) satisfactions about propofol TCI moderate sedation
Time Frame: one day
Patient's satisfactions were measured after endoscopic procedures and 24-48 hours later by visual analog scale (VAS 0-100).
Secondary Outcomes
- Safety (number of partecipants with adverse events) of propofol TCI moderate sedation(one day)
- Time to dischargeability (minutes to reach Modified Aldrete score ≥ 18) of patients(one day)
Investigators
Agostoni Massimo
MD
Ospedale San Raffaele