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

NCT01941888 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2013-09-13

No results posted yet for this study

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).

Conditions

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

Interventions

DRUG

Propofol

DRUG

Midazolam

DEVICE

Target Controlled Infusion

Sponsors & Collaborators

  • Ospedale San Raffaele

    lead OTHER

Principal Investigators

  • Massimo Agostoni, MD · San Raffele Hospital

  • Lorella Fanti, MD · San Raffaele Hospital

  • Marco Gemma, MD · San Raffaele Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01941888 on ClinicalTrials.gov