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

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ospedale San Raffaele
• Treatments: Midazolam; Propofol

Criteria

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