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

Conditions: Management of Intraoperative pain during open colonic resection surgery comparing two different concentrations of epidural fentanyl.
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2011-005802-31-ES

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

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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
;
- 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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): - Time to awakening<br>- Time to postoperative analgesia request<br>- Incidence of secondary effects;Timepoint(s) of evaluation of this end point: Intraoperative and 24h postoperative;Secondary end point(s): - Time to awakening<br>- Time to postoperative analgesia request<br>- Incidence of secondary effects;Timepoint(s) of evaluation of this end point: Intraoperative and 24h postoperative