Universal Clinic Oberig
Kyiv, Ukraine
NCT Number: NCT06619977
Thу goal of this study was to learn whether intraoperative analgesia nociception monitoring (ANI) could be beneficial during intraoperative monitoring for patients undergoing living donor liver resections. The main questions it aims to answer are:
* Could it impact the average dose of intraoperative fentanyl used? * Could it impact the occurrence of postoperative nausea and vomiting?
Patients who were included in this study underwent living liver donor resections with fentanyl infusion and thoracic epidural analgesia. Two groups of patients were analysed - the ANI group (n = 24), in which fentanyl dose was adjusted with ANI monitoring, and the retrospective control group (n = 25) with a standard practice without ANI monitoring.
Looking for future studies?
Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Kyiv, Ukraine
Monitoring nociception accurately during general anaesthesia has presented a long-standing difficulty. Typically, anaesthesiologists rely on changes in the autonomic nervous system, such as heart rate, blood pressure, and sweating, to help determine the need for pain relief medication. Analgesia nociception index (ANI) is a noninvasive tool for monitoring the intraoperative state of the autonomic nervous system, particularly the parasympathetic nervous system.
During the long-lasting high nociceptive surgery, the infusion of fentanyl was used at our institution. Opioids can lead to postoperative nausea, vomiting, and other complications when an overdose occurs. Fentanyl dosage changes significantly after hours of infusion due to context-sensitive halftime. It is practically impossible to adjust an infusion dose with the subjective evaluation of standard monitoring, such as heart rate and blood pressure. Doses of opioids that we use in our daily practice, e.g. mcg.kg-1, are unpredictable and vary between individuals due to pharmacogenetics and pharmacokinetic reasons. The best method to exclude pharmacokinetic peculiarities and predict the subsequent dose is to directly measure analgesic agents' concentration in the blood, though it is practically impossible. This study aimed to assess whether intraoperative analgesia nociception monitoring (ANI) could have an impact on the average intraoperative dose of fentanyl and on the occurrence of postoperative nausea and vomiting.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Analgesia nociception index (ANI; MetroDoloris Medical Systems, Lille, France) is a noninvasive tool for monitoring the intraoperative state of the autonomic nervous system, in particular - the parasympathetic nervous system. The ANI algorithm uses data from one lead ECG trace. Heart rate variability, or the beat-to-beat alterations in heart rate, is a well-known and recognised noninvasive indicator of autonomic nervous system activity.
Time frame: from enrollment to the first 48 hours postoperatively
Bogomolets National Medical University
Other
Analgesia Nociception Index (ANI) for Guiding Intraoperative Opioid Administration During Living Donor Liver Resection and Its Impact on Postoperative Nausea and Vomiting
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07655167
Behavior, Behavioral Symptoms
Manouba, Tunisia
View Trial DetailsNCT07640958
No Disease or Condition is Being Studied
Ankara, Turkey (Türkiye)
View Trial DetailsNCT06638996
Anxiety Disorders, Mental Disorders
Pullman, Washington, United States
View Trial DetailsNCT07041918
No Disease or Condition is Being Studied
Izmir, Karşıyaka, Turkey (Türkiye)
View Trial Details