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moderate sedation during endoscopy of the gastrointestinal tract

Propofol TCI (Target Controlled Infusion) vs. Fentanyl plus Midazolam for moderate sedation during endoscopy diagnostic procedures: a prospective, double-blind randomized trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-001755-40-IT
Enrollment
Unknown
Registered
2012-05-31
Start date
2012-05-04
Completion date
Unknown
Last updated
2014-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastrointestinal tract patologies MedDRA version: 15.1 Level: SOC Classification code 10017947 Term: Gastrointestinal disorders System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Trade Name: DIPRIVAN*INFUS 50ML 20MG/ML Pharmaceutical Form: Emulsion for infusion INN or Proposed INN: PROPOFOL CAS Number: 2078-54-8 Concentration unit: mg/ml milligram(s)/millilitre Concentration t

Sponsors

OSPEDALE S. RAFFAELE DI MILANO
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: patients over 18; patients who have given their written consent to study participation; patients class ASA I or II to be subjected to endoscopy or colonoscopy. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 105 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 35

Exclusion criteria

Exclusion criteria: pregnant or breast-feeding patients ; patients unable to give consent; prior surgery of colonic resection.

Design outcomes

Primary

MeasureTime frame
Main Objective: to compare two regimes of moderate sedation (propofol TCI vs standard sedation) during endoscopic diagnostic procedures.;Secondary Objective: adequacy, safety and time of resignation related to patient's recovery time of his duties neuro-psychological post-procedural.;Primary end point(s): patient's satisfaction;Timepoint(s) of evaluation of this end point: 40 minutes—

Secondary

MeasureTime frame
Secondary end point(s): recovery of neuropsychological and post-procedural functions.;Timepoint(s) of evaluation of this end point: 24-72 hours—

Countries

Italy

Contacts

Public ContactGASTROENTEROLOGIA ENDOSCOPIA DIGEST

Fondazione San Raffaele del Monte Tabor

fanti.lorella@hsr.it0226432744

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026