Pharmacodynamic Effects of Propofol and Alfentanil on EEG During Endoscopic Retrograde Cholangiopancreatography (ERCP)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 20
- Primary Endpoint
- EEG alpha power to beta power ratio
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients who under go ERCP who require general anesthesia
Exclusion Criteria
- •ASA> or = 4 , vulnerable groups such as prisoners, patients with physical or mental disabilities and HIV carriers
Arms & Interventions
Sedation with high dose of alfentanil with the presence of propofol
Adjust dose of alfentanil until reaching to the upper limit before adjusting dose of propofol. This aims to have a highest dose of alfentanil during anesthesia.
Intervention: high dose of alfentanil (Drug)
Sedation with low dose of alfentanil with the presence of propofol
Adjust dose of propofol to the upper limit before adjusting dose of alfentanil. This aims to have alfentanil less or equal to 10ng/mL during anesthesia.
Intervention: low dose of alfentanil with propofol (Drug)
Outcomes
Primary Outcomes
EEG alpha power to beta power ratio
Time Frame: Baseline and periprocedural
EEG alpha ratio
Time Frame: baseline and periprocedural
EEG delta ratio
Time Frame: baseline and periprocedural
EEG beta ratio
Time Frame: baseline and periprocedural
Patient State Index (PSI)
Time Frame: baseline and periprocedural
A processed electroencephalogram (EEG) parameter derived from frontal EEG signals. It is being measured continuously by a EEG monitor.
Secondary Outcomes
- Analgesia Nociception Index (ANI)(Baseline and periprocedural)
- Blood pressure(baseline and periprocedural)
- Non-invasive cardiac output(during the whole sedation)
- Heart rate(baseline and periprocedural)
- Peripheral Capillary Oxygen Saturation (SpO₂)(baseline and periprocedural)
- Non-invasive cardiac index(baseline and periprocedural)
- Non-invasive Stroke Volume (SV)(baseline and periprocedural)
Investigators
Chi Kwan Fung
Attendant Physician
China Medical University Hospital