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

ConditionsSedation and Analgesia Cholangiopancreatography, Endoscopic Retrograde Anesthesia, General

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorChi Kwan Fung

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients who under go ERCP who require general anesthesia

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.
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.

Treatment groups

20 Participants

are divided into 2 treatment groups

Group A: Sedation with high dose of alfentanil with the presence of propofolExperimental treatment 1 intervention

Group B: Sedation with low dose of alfentanil with the presence of propofolActive comparator 1 intervention

Trial 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

Secondary outcomes

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.

Time frame

Baseline and periprocedural

Blood pressure

Time frame

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)

Time frame

during the whole sedation

Heart rate

Time frame

baseline and periprocedural

Other outcomes

Frequency of Patient Movement Events

The total number of movement events (defined as gross body motion, limb withdrawal, or head movement) recorded during the procedure

Time frame

Periprocedural

Sponsors and contacts

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Chi Kwan Fung

Lead sponsor

China Medical University Hospital

Sponsor institution

National Yang Ming Chiao Tung University

Collaborator

WeiGong Memorial Hospital

Collaborator

Source ClinicalTrials.gov

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