Postoperative intestinal atony MedDRA version: 7.1 Level: LLT Classification code 10054048
Conditions
Interventions
Trade Name: neurotropan
Product Name: neurotropan
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Cholincitrate
Other descriptive name: Cholincitrate
Concentration unit: mg milligram(
Sponsors
Phönix Laboratorium GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age between 18 and 85 years - Condition following hemicolectomy, sigmoid, transversum or rectal resection without ileostoma without peritonitis - Postoperative intestinal atony (defined as lack of defecation and flatus for 48 hours postoperatively) - Duration of the operation >= 60 minutes - ASA-class = 50 % 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: - Contraindication to the study medication or one of it's constituents (intolerance to study medication or one of it's constituents, hypotension, severe arrrhythmias, increased bronchial tonus, condition following myocardial infarction, Parkinson's disease) - Concomitant treatment with one of the following drugs or members of substance classes: cholinesterase inhibitors, systemic cholinergics, systemic parasympatholytic agents, systemic sympatholytic agents, laxatives, cisapride, metoclopramide, erythromycin, dexpanthenol - Decompression or intestinal massage - Enema
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessment of the efficacy and tolerability of cholin citrate in postoperative intestinal atony following hemicolectomy, sigmoid, transversum or rectal resection without ileostoma without peritonitis;Secondary Objective: ;Primary end point(s): Duration form the end of the operation until the first defecation | — |
Countries
Germany
Outcome results
None listed