NCT02062177

Propofol Administered by Gastroenterologists by Target Controlled Infusion Pump During Endoscopy

Propofol Administered by Gastroenterologists by Target Controlled Infusion Pump During Endoscopy: a Randomized Double Blind Controlled Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Università Vita-Salute San Raffaele · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sedation
• Endoscopy

Interventions

Type	Name	Description
DRUG	Propofol	70 patients (35 upper endoscopy - 35 colonoscopy) are sedated with propofol TCI (Target Controlled Infusion) pump (concentration 1.2-1.6 mcg/ml).
DRUG	Midazolam	70 patients (35 upper endoscopy - 35 colonoscopy) in group midazolam are sedated with midazolam 0.04 mg/Kg if aged \< 70, 0.03 mg/Kg if aged \> 70.

Timeline

• Start date: 2014-02-01
• Primary completion: 2014-02-01
• Completion: 2014-05-01
• First posted: 2014-02-13
• Last updated: 2014-09-08
• Results posted: 2014-09-08

Locations

1 site across 1 country: Italy