EEG and Pain Monitor Data Under Anesthesia to Study Pharmacodynamic Effects of Opioids and Sedatives (SED-ERCP)

Chi Kwan Fung

Status: Not yet enrolling

Conditions: Cholangiopancreatography, Endoscopic Retrograde; Anesthesia, General; Sedation and Analgesia

Treatments: Drug: low dose of alfentanil with propofol; Drug: high dose of alfentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT07211828

CMUH114-REC2-080

Details and patient eligibility

About

Recording and analyzing electroencephalogram (EEG) and continuous pain monitor data under anesthesia in order to investigating the pharmacodynamic effects of opioids and sedatives.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

20 participants in 2 patient groups

Sedation with high dose of alfentanil with the presence of propofol

Experimental group

Description:

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.

Treatment:

Drug: high dose of alfentanil

Sedation with low dose of alfentanil with the presence of propofol

Active Comparator group

Description:

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.

Treatment:

Drug: low dose of alfentanil with propofol