Sedation and AnalgesiaSED-ERCPNCT07211828
EEG and Pain Monitor Data Under Anesthesia to Study Pharmacodynamic Effects of Opioids and Sedatives
A study testing high dose of alfentanil and low dose of alfentanil with propofol in people with Sedation and Analgesia and Cholangiopancreatography, Endoscopic Retrograde, run by Chi Kwan Fung at 1 site in Taiwan.
Trial summary
Recording and analyzing electroencephalogram (EEG) and continuous pain monitor data under anesthesia in order to investigating the pharmacodynamic effects of opioids and sedatives. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sedation and Analgesia, Cholangiopancreatography, Endoscopic Retrograde, Anesthesia, General
- What is being tested?
- high dose of alfentanil and low dose of alfentanil with propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Oct 2025to 16 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who under go ERCP who require general anesthesia
Who cannot join
- ASA> or = 4 , vulnerable groups such as prisoners, patients with physical or mental disabilities and HIV carriers
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Wei Gong Memorial Hospital
Miaoli
Chi Kwan Boris Fung, MD, 886-037-676818, 024666@tool.caaumed.org.tw
About this study
Official title: Pharmacodynamic Effects of Propofol and Alfentanil on EEG During Endoscopic Retrograde Cholangiopancreatography (ERCP)
Recording and analyzing electroencephalogram (EEG) and continuous pain monitor data under anesthesia in order to investigating the pharmacodynamic effects of opioids and sedatives.
Read the 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.
- Conditions
- Sedation and Analgesia, Cholangiopancreatography, Endoscopic Retrograde, Anesthesia, General
- Being tested
- high dose of alfentanil, low dose of alfentanil with propofol
- Keywords
- sedation, phramacodynamics, opioid, ERCP
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high dose of alfentanilDrug
Also called Alfenta, Alfentanil hydrochloride, Propofol (Diprivan)
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.
low dose of alfentanil with propofolDrug
Also called Propofol (Diprivan), Alfenta, Alfentanil hydrochloride
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: low dose of alfentanil with propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG alpha power to beta power ratio
Measured: Baseline and periprocedural
EEG alpha ratio
Measured: baseline and periprocedural
EEG delta ratio
Measured: baseline and periprocedural
EEG beta ratio
Measured: 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.
Measured: baseline and periprocedural
Secondary outcomes (7)
Analgesia Nociception Index (ANI)
The Analgesia Nociception Index is measured by a continuous analgesia monitoring system . It is a numeric index (range from 0-100) indicating patients' nociception.
Measured: Baseline and periprocedural
Blood pressure
Measured: baseline and periprocedural
Non-invasive cardiac output
Cardiac output measured continuously by non-invasive monitoring (e.g., electrical cardiometry or equivalent device). The unit of measure is liters per minute (L/min)
Measured: during the whole sedation
Heart rate
Measured: baseline and periprocedural
Peripheral Capillary Oxygen Saturation (SpO₂)
Continuous non-invasive measured by pulse oximetry,
Measured: baseline and periprocedural
Non-invasive cardiac index
Cardiac index calculated as cardiac output normalized to body surface area, measured non-invasively. The unit of measure is liters per minute per square meter (L/min/m²)
Measured: baseline and periprocedural
Non-invasive Stroke Volume (SV)
Stroke volume measured non-invasively, defined as the volume of blood ejected from the left ventricle per heartbeat.
Measured: baseline and periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start10 Oct 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion16 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedation and AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chi Kwan Fung
- Sponsor type
- University, hospital or other
- Collaborators
- National Yang Ming Chiao Tung University, WeiGong Memorial Hospital
- Responsible party
- Sponsor-investigator, Chi Kwan Fung, China Medical University Hospital
- Investigators
- Chi Kwan Boris Fung, MD, Principal investigator, Wei Gong Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07211828
- Sponsor's protocol ID
- CMUH114-REC2-080
- Acronym
- SED-ERCP
- Status last verified
- Sep 2025
- First submitted
- 31 Aug 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacodynamic Effects of Propofol and Alfentanil on EEG During Endoscopic Retrograde Cholangiopancreatography (ERCP)
- ClinicalTrials.gov ID
- NCT07211828
- Acronym / sponsor ID
- SED-ERCP / CMUH114-REC2-080
- Conditions
- Sedation and Analgesia, Cholangiopancreatography, Endoscopic Retrograde, Anesthesia, General
- Keywords
- sedation, phramacodynamics, opioid, ERCP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Chi Kwan FungUniversity, hospital or other
- Collaborators
- National Yang Ming Chiao Tung University, WeiGong Memorial Hospital
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 16 Jun 2028 (estimated)
- First posted
- 8 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sedation with high dose of alfentanil with the presence of propofol | Experimental | Drug: high dose of alfentanilAdjust 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. |
| Sedation with low dose of alfentanil with the presence of propofol | Active comparator | Drug: low dose of alfentanil with propofolAdjust 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who under go ERCP who require general anesthesia
Key exclusion criteria (1 listed)
- ASA> or = 4 , vulnerable groups such as prisoners, patients with physical or mental disabilities and HIV carriers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high dose of alfentanilAlso: Alfenta, Alfentanil hydrochloride, Propofol (Diprivan)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 | Sedation with high dose of alfentanil with the presence of propofol |
| low dose of alfentanil with propofolAlso: Propofol (Diprivan), Alfenta, Alfentanil hydrochlorideAdjust 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. | Drug | Sedation with low dose of alfentanil with the presence of propofol |
Primary outcome
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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chi Kwan Boris Fung, MD principal investigator
Wei Gong Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high dose of alfentanil and low dose of alfentanil with propofol in people with Sedation and Analgesia and Cholangiopancreatography, Endoscopic Retrograde, run by Chi Kwan Fung at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chi Kwan Boris Fung, MD (886-037-676811, 024666@tool.caaumed.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG alpha power to beta power ratio (time frame: Baseline and periprocedural). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.