Propofol TCI Administered by Gastroenterologists During Endoscopy: a Randomized Double Blind Controlled Study — PropTCI/2012  

Propofol Clinical Trial

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

Status Completed

Clinical Trial 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).

Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastrointestinal Endoscopy
• Moderate Sedation
• Propofol
• Target Controlled Infusion

• NCT number: NCT01941888
• Study type: Interventional
• Source: Ospedale San Raffaele
• Status: Completed
• Phase: Phase 4
• Start date: May 2012
• Completion date: March 2013