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Clinical Trials/NCT05313789
NCT05313789
Unknown
Not Applicable

Analgesia Nociception Index for Pain Monitoring in Intensive Care Units

İstanbul Yeni Yüzyıl Üniversitesi0 sites180 target enrollmentApril 11, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress Related Disorder
Sponsor
İstanbul Yeni Yüzyıl Üniversitesi
Enrollment
180
Primary Endpoint
Analgesia Nociception Index for pain monitorization
Last Updated
4 years ago

Overview

Brief Summary

The aim of this study is to examine the usability of ANI in patients who will be treated in intensive care unit.

Detailed Description

The aim of this study is to examine the usability of Analgesia Nociception Index in patients who will be treated in intensive care unit ( a- Cardiovascular b- surgical c- internal diseases), mechanically ventilated and lacking communication. The investigators will examine whether the positive inotropic/vasoconstrictor agents will have any effect on Analgesia Nociception Index.

Registry
clinicaltrials.gov
Start Date
April 11, 2022
End Date
June 6, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
İstanbul Yeni Yüzyıl Üniversitesi
Responsible Party
Principal Investigator
Principal Investigator

Ali Sefik Koprulu, MD, Ass. Prof.

Ass. Prof.

İstanbul Yeni Yüzyıl Üniversitesi

Eligibility Criteria

Inclusion Criteria

  • Intensive Care Cardiovascular Patients Group 1 - Patients aged from 18 to 80 years, scheduled for elective isolated coronary bypass graft (CABG) for 2-4 vessel disease, without any perioperative complications, and who were postoperatively monitored via the analgesia nociception index in the cardiovascular intensive care will be included.
  • Intensive Care Internal Diseases Group 2 - Patients aged from 18 to 80 years, intubated or tracheostomized, In mechanical ventilation with Pressure-Controlled Ventilation mode, under perfusion neuromuscular blocker, Normothermic, non-cooperative and/or sedated and neuromuscular blocker
  • Intensive Care Patients (Obese) Group 3 - Post Bariatric surgery, over 40 BMI

Exclusion Criteria

  • Intensive Care Cardiovascular Patients Group 1 Patients who required emergency surgery, had significant preoperative chronic pain, had autonomic nervous system anomalies and patients with rhythm will be excluded from the study.
  • Intensive Care Internal Diseases Group 2 Ramsey sedation scale under 5, cooperative, with spontaneous breathing effort and extremity movement, non sinusal cardiac rhythm
  • Intensive Care Patients (Obese) Group 3 - patients under 40 BMI

Outcomes

Primary Outcomes

Analgesia Nociception Index for pain monitorization

Time Frame: 3 Months

The duration between two R waves within heart rate variations (filtering the variations in respiratory cycles). A numeric measure of parasympathetic tonus will be obtained. This variation is between (pΣ) 0 and 100.

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