Remifentanil administered by controlled tecnique PCSA by patients versus Meperidina administered by physician for diagnostic and operative endoscopic procedures. - ND

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-003072-19-IT

Enrollment

Registered

2007-07-03

Start date

2007-06-20

Completion date

Unknown

Last updated

2021-10-26

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

Conditions

patients undergoing diagnostic or operative procedures of endoscopic type with planned sadation MedDRA version: 6.1 Level: SOC Classification code 10017947

Interventions

Trade Name: ULTIVA Pharmaceutical Form: Solution for infusion INN or Proposed INN: Remifentanil Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Trade Name: PETI

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: patients aged more than 18 years old undergoing diagnostic and operative procedures of endoscopic type on gastroenteric tract for which is planned a sedation. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: patients aged less than 18 anni

Design outcomes

Primary

Measure	Time frame
Main Objective: To verify the efficacy of Remifentanil in assuring appropriate anlgesia and more rapid recovery without incidence of post procedural adverse events;Secondary Objective: To verify the efficacy of Remifentanil in assuring appropriate anlgesia and more rapid recovery without incidence of post procedural adverse events.;Primary end point(s): To verify the efficacy of Remifentanil in assuring appropriate anlgesia and more rapid recovery without incidence of post procedural adverse events	—

Measure

Time frame

Main Objective: To verify the efficacy of Remifentanil in assuring appropriate anlgesia and more rapid recovery without incidence of post procedural adverse events;Secondary Objective: To verify the efficacy of Remifentanil in assuring appropriate anlgesia and more rapid recovery without incidence of post procedural adverse events.;Primary end point(s): To verify the efficacy of Remifentanil in assuring appropriate anlgesia and more rapid recovery without incidence of post procedural adverse events

—

Countries

Italy

Outcome results

None listed

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