Analgesia Nociception Index for Pain Monitoring in Intensive Care Units

Pain Clinical Trial

Official title:

Analgesia Nociception Index for Pain Monitoring in Intensive Care Units

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05313789
• Other study ID #: 20180413.2018/04-2
• Status: Not yet recruiting
• Start date: April 11, 2022
• Est. completion date: June 6, 2022

Study information

• Verified date: March 2022
• Source: Istanbul Yeni Yüzyil Üniversitesi
• Contact: Ali Sefik Koprulu, MD
• Phone: +905322677226
• Email: sefik.koprulu[@]yeniyuzyil.edu.tr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: June 6, 2022
• Est. primary completion date: May 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Intensive Care Unit Syndrome
• Pain
• Stress Related Disorder

Intervention

Device:
• Analgesia Nociception Index (ANI)
Monitorization of Analgesia Nociception Index in Intensive Care Patients

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Yeni Yüzyil Üniversitesi

References & Publications (6)

Broucqsault-Dédrie C, De Jonckheere J, Jeanne M, Nseir S. Measurement of Heart Rate Variability to Assess Pain in Sedated Critically Ill Patients: A Prospective Observational Study. PLoS One. 2016 Jan 25;11(1):e0147720. doi: 10.1371/journal.pone.0147720. eCollection 2016. — View Citation

Dias Dde S, Resende MV, Diniz Gdo C. Patient stress in intensive care: comparison between a coronary care unit and a general postoperative unit. Rev Bras Ter Intensiva. 2015 Jan-Mar;27(1):18-25. doi: 10.5935/0103-507X.20150005. Epub 2015 Mar 1. English, Portuguese. — View Citation

Jeanne M, Clément C, De Jonckheere J, Logier R, Tavernier B. Variations of the analgesia nociception index during general anaesthesia for laparoscopic abdominal surgery. J Clin Monit Comput. 2012 Aug;26(4):289-94. doi: 10.1007/s10877-012-9354-0. Epub 2012 Mar 28. — View Citation

Jendoubi A, Abbes A, Ghedira S, Houissa M. Pain Measurement in Mechanically Ventilated Patients with Traumatic Brain Injury: Behavioral Pain Tools Versus Analgesia Nociception Index. Indian J Crit Care Med. 2017 Sep;21(9):585-588. doi: 10.4103/ijccm.IJCCM_419_16. — View Citation

Le Guen M, Jeanne M, Sievert K, Al Moubarik M, Chazot T, Laloë PA, Dreyfus JF, Fischler M. The Analgesia Nociception Index: a pilot study to evaluation of a new pain parameter during labor. Int J Obstet Anesth. 2012 Apr;21(2):146-51. doi: 10.1016/j.ijoa.2012.01.001. Epub 2012 Feb 21. — View Citation

Soral M, Altun GT, Dinçer PÇ, Arslantas MK, Aykaç Z. Effectiveness of the Analgesia Nociception Index Monitoring in Patients Who Undergo Colonoscopy with Sedo-Analgesia. Turk J Anaesthesiol Reanim. 2020 Feb;48(1):50-57. doi: 10.5152/TJAR.2019.45077. Epub 2019 Sep 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analgesia Nociception Index for pain monitorization	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 (pS) 0 and 100.	3 Months