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Propofol Administered by Gastroenterologists by Target Controlled Infusion Pump During Endoscopy

NCT02062177 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2014-09-08

Study results available
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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

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.

Sponsors & Collaborators

  • Università Vita-Salute San Raffaele

    lead OTHER

Principal Investigators

  • Pier Alberto Testoni, Professor · Vita-Salute San Raffalele University- 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
2014-02-28
Primary Completion
2014-02-28
Completion
2014-05-31

Countries

  • Italy

Study Locations

More Related Trials

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 NCT02062177 on ClinicalTrials.gov