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Comparison of efficacy of epidural fentanyl administered at two different concentrations.

Comparison of the analgesic efficacy of two different concentrations of epidural fentanyl (25mcg/ml and 8mcg/ml)to provide intraoperative analgesia. - PERIFENTA-2

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-005802-31-ES
Enrollment
Unknown
Registered
2012-06-22
Start date
2012-08-23
Completion date
Unknown
Last updated
2012-09-11

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

Conditions

Management of Intraoperative pain during open colonic resection surgery comparing two different concentrations of epidural fentanyl.

Interventions

Trade Name: Fentanest Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: FENTANYL CAS Number: 437-38-7 Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equa

Sponsors

Consorci Mar Parc de Salut de Barcelona (Parc de Salut Mar)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Age >18 years old - Open colonic neoplasic surgery - Signature of informed consent 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40 ;Inclusion criteria: - Age >18 years old - Open colonic neoplasic surgery - Signature of informed consent 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: - Impossibility of epidural catheterisation - Severe lung disease - Chronic opioid treatment - Negative to sign informed consent ;Exclusion criteria: - Impossibility of epidural catheterisation - Severe lung disease - Chronic opioid treatment - Negative to sign informed consent

Design outcomes

Primary

MeasureTime frame
Primary end point(s): Intraoperative remifentanyl compsumption;Timepoint(s) of evaluation of this end point: Intraoperative period;Main Objective: Comparing two different concentrations of epidural fentanyl to mantain intraoperative analgesia (in terms of necessity of remifentanyl);Secondary Objective: Differences in time to awakening, analgesia request and incidence of secondary effects.;Primary end point(s): Intraoperative remifentanyl compsumption;Timepoint(s) of evaluation of this end point: Intraoperative period;Main Objective: Comparing two different concentrations of epidural fentanyl to mantain intraoperative analgesia (in terms of necessity of remifentanyl);Secondary Objective: Differences in time to awakening, analgesia request and incidence of secondary effects.—

Secondary

MeasureTime frame
Secondary end point(s): - Time to awakening - Time to postoperative analgesia request - Incidence of secondary effects;Timepoint(s) of evaluation of this end point: Intraoperative and 24h postoperative;Secondary end point(s): - Time to awakening - Time to postoperative analgesia request - Incidence of secondary effects;Timepoint(s) of evaluation of this end point: Intraoperative and 24h postoperative—

Countries

Spain

Contacts

Public ContactMarc Sadurní Sardà;Marc Sadurní Sardà ;

Departament d'Anestesiologia;Departament d'Anestesiologia

97162@parcdesalutmar.cat;97162@parcdesalutmar.cat34932483350;34932483350

Outcome results

None listed

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