Status:
COMPLETED
Efficiency and Safety a Fixed Combination of Orphenadrine and Diclofenac for Postoperative Analgesia
Lead Sponsor:
Petrovsky National Research Centre of Surgery
Conditions:
Analgesia
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
The patient signs an informed consent to participate in the study after tracheal extubation.The application of one or another method of influence is carried out by the method of random sampling (the e...
Eligibility Criteria
Inclusion
- age from 18 years to 80 years inclusive
- surgical access - median sternotomy
- the first 2 hours after tracheal extubation
- clear consciousness and productive contact with the patient
- 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
- no signs of renal dysfunction (KDIGO 0)
- stable state of hemodynamics
Exclusion
- a history of mental illness
- the presence of contraindications to the appointment of diclofenac and orphenadrine or individual intolerance to drugs of these groups
- renal and hepatic insufficiency
- perioperative brain lesions
- postoperative bleeding\>1.4 ml/kg/hour
- severe cardiovascular (inotropic index\>10) and/or respiratory (RaO2 /FiO2\<200 mmHg) insufficiency
Key Trial Info
Start Date :
March 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 20 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05322603
Start Date
March 18 2022
End Date
August 20 2022
Last Update
August 22 2023
Active Locations (1)
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1
Petrovsky Research National Centre of Surgery
Moscow, Russia