Propofol Administered by Gastroenterologists by Target Controlled Infusion Pump During Endoscopy: a Randomized Double Blind Controlled Study
Overview
- Phase
- Phase 4
- Intervention
- Propofol
- Conditions
- Sedation
- Sponsor
- Università Vita-Salute San Raffaele
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Endoscopist's Satisfaction (Visual Analog Scale) About Sedation
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Investigators
Testoni Pier Alberto
Professor
Università Vita-Salute San Raffaele
Eligibility Criteria
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
Arms & Interventions
propofol group
70 patients (35 upper endoscopy - 35 colonoscopy)
Intervention: Propofol
midazolam group
70 patients (35 upper endoscopy - 35 colonoscopy)
Intervention: Midazolam
Outcomes
Primary Outcomes
Endoscopist's Satisfaction (Visual Analog Scale) About Sedation
Time Frame: at the end of the exam
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
Patient's Satisfaction (Visual Analog Scale) About Sedation 24-72 Hours After Procedure
Time Frame: at 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)
Patient's Satisfaction (Visual Analog Scale) About Sedation Before Discharge
Time Frame: 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)
Secondary Outcomes
- Number of Participants With Adverse Events as a Measure of Safety(one day)
- Time (Minutes) to Dischargeability of Patient From Endoscopic Unit(one day)