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EFFECT OF REMIFENTANIL AND PRPOPOFOL TIMING ADMINISTRATION ON THE DEEPNESS OF HYPNOSIS. - ND

EFFECT OF REMIFENTANIL AND PRPOPOFOL TIMING ADMINISTRATION ON THE DEEPNESS OF HYPNOSIS. - ND

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-001174-25-IT
Enrollment
60
Registered
2007-04-04
Start date
2006-03-13
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 SURGERY WITH LOCOREGIONAL ANAESTHESIA AND SEDATION MedDRA version: 9.1 Level: SOC Classification code 10042613 Term: Surgical and medical procedures

Interventions

Trade Name: ULTIVA IV 5FL 2MG Pharmaceutical Form: Solution for infusion INN or Proposed INN: Remifentanil CAS Number: 132539-07-2 Concentration unit: mg milligram(s) Concentration type: equal Concent

Sponsors

OSPEDALE S. RAFFAELE
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: PATIENTS BETWEEN 18 AND 75 YEARS OLD PROPOSED AS CANDIDATE FOR SURGERY WITH LOCO REGIONAL ANAESTHESIA 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: POLOMONAR,CARDIAC OR RENAL PATOLOGIES; SEVERE DISLIPIDEMIA; OVERDOSE OF DRUGS, ALCOOL; BODY MASS INDEX 30; PATIENTS WITH SNC DISEASE ETC.

Design outcomes

Primary

MeasureTime frame
Main Objective: TO EVALUATE IF ADMINISTRATION TIMING OF THE 2 DRUGS, CAN MUTUALLY CONDITIONING THE HYPNOSI LEVEL THROUGH THE MONITORING OF THE HYPNOTIC DEPRESSANT LEVEL BY BIS BISPECTRAL INDEX .;Secondary Objective: ;Primary end point(s):

Countries

Italy

Outcome results

None listed

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