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Recruiting NCT05762666

Nociception Level Index as Monitorization of Pain at the Intensive Care

Conditions: Intensive Care, Surgical, Anesthesia, General

Sex: All
Ages: 18 Years – 90 Years
Phase: NA
Enrollment: 60
Sponsor: Haseki Training and Research Hospital

Location: Turkey

Summary

The aim of our study is to evaluate the effectiveness of a nociception monitor in providing adequate postoperative analgesia for patients needing critical care after surgery. Besides, the study searches to determine the difference between the amount of analgesic medication used when guided by nociception or standard pain management protocols. It is also aimed to reveal the incidence of delirium when pain management is managed under the nociception level index (NOL) guidance.60 postoperative patients admitted to the postanesthesia care unit (PACU) after general anesthesia for surgery for more than 2 hours will be included and allocated into 2 groups(n=30): the control group (Group A) and the study group (Group B). Group Standard of care will be followed with standard monitorization only along with pain scales and receive rescue analgesia according to them. However, Group NOL will acquire NOL monitorization throughout the ICU stay and have the same rescue analgesia under NOL guidance with concurrent pain scales. Data to be recorded are total postoperative analgesic consumption, NOL values along with CPOT scores, and delirium.

Eligibility Criteria

Inclusion Criteria:American Society of Anesthesiologists (ASA) Physical Status classification I to IIIPatients who have been admitted to the postoperative intensive care unitPatients necessitating general anesthesia for surgery of more than 2 hoursPatients who need mechanical ventilation for a while in intensive care follow-upExclusion Criteria:Patients with additional organ failureDisease that may make it difficult to wean from the ventilator when lung functions are evaluated (Pao2/fio2 value below 200)History of allergies to drugs used in the study protocolPatients receiving deep anesthesia with sedation infusion RASS -2 (unable to be awakened by uncooperative audible stimulus)Patients with head trauma expected to have a low postoperative Glasgow coma scorePresence of arrhythmiaPresence of sepsis during the hospital stayPatients who stay more than 48 hours at the postoperative intensive care unitPresence of surgical complicationKnown hepatic insufficiency or decreased functionKnown renal insufficiency or decreased function

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05762666). StuddyBuddy aggregates publicly available trial information.