Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2025-12-24 @ 7:40 PM
NCT ID:
NCT05322603
Eligibility Criteria:
Inclusion Criteria:
1. age from 18 years to 80 years inclusive
2. surgical access - median sternotomy
3. the first 2 hours after tracheal extubation
4. clear consciousness and productive contact with the patient
5. absence of erosive or ulcerative lesions of the mucous membrane of the esophagus, stomach and duodenum during preoperative esophago-gastro-duodenoscopy and clinical manifestations of gastrointestinal bleeding
6. no signs of renal dysfunction (KDIGO 0)
7. stable state of hemodynamics
Exclusion Criteria:
1. a history of mental illness
2. the presence of contraindications to the appointment of diclofenac and orphenadrine or individual intolerance to drugs of these groups
3. renal and hepatic insufficiency
4. perioperative brain lesions
5. postoperative bleeding\>1.4 ml/kg/hour
6. severe cardiovascular (inotropic index\>10) and/or respiratory (RaO2 /FiO2\<200 mmHg) insufficiency
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05322603
Study Brief:
Protocol Section:
NCT05322603