Analgesia Clinical Trial
Official title:
Efficiency and Safety a Fixed Combination of Orphenadrine and Diclofenac for Postoperative Analgesia in Cardiac Surgery Patients
NCT number | NCT05322603 |
Other study ID # | 00191200 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 18, 2022 |
Est. completion date | August 20, 2022 |
Verified date | August 2023 |
Source | Petrovsky National Research Centre of Surgery |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study will include 60 patients after cardiac surgery. The first group will include 30 patients who will use the drug Neodolpasse manufactured by Fresenius Kabi, which is a fixed combination of 30 mg of orphenadrine and 75 mg of diclofenac; the second group will consist of 30 patients who will use patient-controlled morphine analgesia (РСА) in the form of monotherapy.
Status | Completed |
Enrollment | 60 |
Est. completion date | August 20, 2022 |
Est. primary completion date | August 20, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Petrovsky Research National Centre of Surgery | Moscow |
Lead Sponsor | Collaborator |
---|---|
Petrovsky National Research Centre of Surgery |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | visual-analog scale | dynamics of points 100 mm visual-analog scale | hospitalisation period, an average of 24 hours | |
Secondary | the minute inspiratory lung volume using a spirometer | Comparison of minute inspiratory lung volume befor/after research using a spirometer | hospitalisation period, an average of 24 hours | |
Secondary | opioid-sparing effect | Comparison of the number of opioid analgesics | hospitalisation period, an average of 24 hours | |
Secondary | adverse events | registration of adverse events | hospitalisation period, an average of 1 week |
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