Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-26 @ 10:33 AM
Ignite Modification Date: 2025-12-26 @ 10:33 AM
NCT ID: NCT07211828
Brief Summary: Recording and analyzing electroencephalogram (EEG) and continuous pain monitor data under anesthesia in order to investigating the pharmacodynamic effects of opioids and sedatives.
Detailed Description: The Patient State Index (PSI) is the main instrument used for monitoring brain waves during anesthesia. By using conductive patches to detect frontal lobe brainwave patterns, PSI helps assess the patient's depth of anesthesia. The Analgesia Nociception Index (ANI) is a heart rate variability (HRV)-based indicator that evaluates the activity of the autonomic nervous system (sympathetic and parasympathetic), thereby reflecting the patient's pain or stress response. PSI and ANI are often used together in anesthetized patients to avoid drug overdose. Since opioids and sedative drugs interact with each other, different doses of opioids and sedatives have varying effects on brain waves, PSI, and ANI. This interaction has recently become a focus in anesthesiology and critical care medicine. The purpose of this study is to use target-controlled infusion (TCI) to continuously administer opioids and sedative drugs, and to observe changes in the Patient State Index (PSI), raw EEG, and ANI data during the anesthesia process, in order to identify the effects of opioids and sedatives on PSI, EEG, and ANI.
Study: NCT07211828
Study Brief:
Protocol Section: NCT07211828