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Recruiting NCT07211828

EEG and Pain Monitor Data Under Anesthesia to Study Pharmacodynamic Effects of Opioids and Sedatives

No phase Interventional Sedation and Analgesia Cholangiopancreatography, Endoscopic Retrograde Anesthesia, General

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: high dose of alfentanil, low dose of alfentanil with propofol.
Who it may be relevant to
Registry conditions: Sedation and Analgesia, Cholangiopancreatography, Endoscopic Retrograde, Anesthesia, General. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Pharmacodynamic Effects of Propofol and Alfentanil on EEG During Endoscopic Retrograde Cholangiopancreatography (ERCP)

Overview

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.

Interventions

  • Drug high dose of alfentanil
    The initial dose is alfentanil cet 10ng/mL and propofol 1ug/mL. Dose of alfentanil will be increased by 10ng/mL each until PSI reach to 25-50. If alfentail has been adjusted to 50 but PSI is still too high, increase propofol cet by 0.5-1ug/mL till target PSI is reached. If propofol is adjusted to 0 but PSI is still too low, decrease alfetanil by 10ng/mL The range of dosage of alfentanil is 0-50ng/mL while propofol is 0-5ug/mL.
  • Drug low dose of alfentanil with propofol
    Adjust dose of propofol to the upper limit before adjusting dose of alfentanil. Increase dose of propofol 0.5-1 ug/mL in order to have PSI valued 25-50. The initial dose of propofol is 1ug/mL, alfentanil 10 ng/mL. If propofol was adjusted to cet=5 ug/mL but PSI is still too high, increase alfentanil by 10 ng/mL instead. If alfentanil was adjusted to 0 but PSI is still too low, decrease propofol by 0.5-1 ug/mL instead . The range of dosage of propofol is 0-5 ug/mL while alfentanil is 0-50ng/mL.

Primary outcome measures

  • 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]
Secondary outcome measures (7)
  • Analgesia Nociception Index (ANI) [Time frame: Baseline and periprocedural]
  • Blood pressure [Time frame: baseline and periprocedural]
  • Non-invasive cardiac output [Time frame: during the whole sedation]
  • Heart rate [Time frame: baseline and periprocedural]
  • Peripheral Capillary Oxygen Saturation (SpO₂) [Time frame: baseline and periprocedural]
  • Non-invasive cardiac index [Time frame: baseline and periprocedural]
  • Non-invasive Stroke Volume (SV) [Time frame: baseline and periprocedural]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Other

Study locations

Taiwan · 1 center
  • Wei Gong Memorial Hospital — Miaoli

Identifiers

NCT: NCT07211828 · CMUH114-REC2-080

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗