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

Efficiency and Safety a Fixed Combination of Orphenadrine and Diclofenac for Postoperative Analgesia | DecenTrialz