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

NCT07211828 | Recruiting

• 1 other identifier: CMUH114-REC2-080
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

sedation; phramacodynamics; opioid; ERCP

Outcome Measures

Primary Outcomes (5)

• EEG alpha power to beta power ratio

  Baseline and periprocedural

• EEG alpha ratio

  baseline and periprocedural

• EEG delta ratio

  baseline and periprocedural

• EEG beta ratio

  baseline and periprocedural

• Patient State Index (PSI)

  A processed electroencephalogram (EEG) parameter derived from frontal EEG signals. It is being measured continuously by a EEG monitor.

  baseline and periprocedural

Secondary Outcomes (7)

• 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

Other Outcomes (1)

• Frequency of Patient Movement Events

  Periprocedural

Study Arms (2)

Sedation with high dose of alfentanil with the presence of propofol

EXPERIMENTAL

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.

Drug: high dose of alfentanil

Sedation with low dose of alfentanil with the presence of propofol

ACTIVE COMPARATOR

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.

Drug: low dose of alfentanil with propofol

Interventions

high dose of alfentanil DRUG

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.

Also known as: Alfenta, Alfentanil hydrochloride, Propofol (Diprivan)

Sedation with high dose of alfentanil with the presence of propofol

low dose of alfentanil with propofol DRUG

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.

Also known as: Propofol (Diprivan), Alfenta, Alfentanil hydrochloride

Sedation with low dose of alfentanil with the presence of propofol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who under go ERCP who require general anesthesia

You may not qualify if:

• ASA\> or = 4 , vulnerable groups such as prisoners, patients with physical or mental disabilities and HIV carriers

Sponsors & Collaborators

• WeiGong Memorial Hospital: collaborator
• Chi Kwan Fung: lead
• National Yang Ming Chiao Tung University: collaborator

Study Sites (1)

Wei Gong Memorial Hospital

Miaoli, Taiwan

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

Alfentanil; Propofol

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Chi Kwan Boris Fung, MD

  Wei Gong Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chi Kwan Boris Fung, MD

CONTACT

886-037-676811; 024666@tool.caaumed.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attendant Physician

Study Record Dates

• First Submitted: August 31, 2025
• First Posted: October 8, 2025
• Study Start: October 10, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 16, 2028
• Last Updated: March 27, 2026

Record last verified: 2025-09

Locations

TW (1)