Evaluation of the early use of norepinephrine in major abdominal surgery on postoperative organ dysfunctio

Phase 1

• Conditions: major abdominal surgery; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2021-001827-41-FR
• Lead Sponsor: CHU Amiens-Picardie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-08
• Last Update Posted: 10 January 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

•Adult > 50 years
•Major abdominal surgery
•Weighing more than 50 kg
•ASA 2 or more
•General 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 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

opatient allergic to local anesthetics,
oinfection at the puncture sites,
opatient on morphine analgesic over the long term,
opatient on antidepressants for neuropathic pain.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: is to show the effectiveness of the preventive use of noradrenaline in major abdominal surgery on the occurrence of postoperative medical-surgical complication;Secondary Objective: - Length of hospital stay and length of stay in the ICU <br>- Post-operative renal function at 48 hours, 7 days and 1 month post-operatively.<br>- Post-operative cardiovascular complications occurring during the stay <br>- Post-operative respiratory complications occurring during the stay <br>- Infectious complications <br>- Neurological complications <br>- Haematological complications <br>- Volume of intraoperative vascular filling with crystalloids recorded at the end of the operation<br>- Mortality at 1 month<br>- Evaluation of the level of dependence in activities of daily living<br>;Primary end point(s): is the occurrence of postoperative medical-surgical complications assessed by the Clavien Dindo surgical score.<br><br>;Timepoint(s) of evaluation of this end point: day 30