The Application of Response Surface Model on Sedative Procedures

NCT04318457 | Unknown

• 1 other identifier: 2019-01-007BC
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to find the application of Response Surface Model on Sedative Procedures.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (2)

• Response Surface Models

  Pharmacodynamic response surface model is a mathematic model which provides information about when and what extent the patient will response to a specific physiological condition (pain, respiratory depression, anesthesia depth….) in a given combination drug concentration pairs. The calculated plasma or effect concentration of specific medications will be used to train iteratively by non-linear regression to find the optimal parameters to construct a new response surface model. Then the model will be validated by the observation data to see the accuracy and efficacy of the model.

  10 seconds from once the anesthetics were terminated to 10 minutes after the time of each patient's wake up

• Evaluation of Response Surface Model Predictions

  Model predictions were evaluated at the emergence period of moderate sedation or general anesthesia. Model predictions of OAA/S ranging from 0% to 100% were made every 10 seconds from once the anesthetics were terminated to 10 minutes after the time of each patient's wake up. Model predictions were compared with observations with graphical and temporal analyses

  10 seconds from once the anesthetics were terminated to 10 minutes after the time of each patient's wake up

Study Arms (2)

Brochoscopy

20 ASA Class II-III, aged 20-80 adult patients who require moderate sedation during bronchoscopy will be enrolled into this study. The moderate sedation will be performed only after patients' inform consents and approval of the institutional ethics committee. Patients with conditions such as neurological disorders, hearing impairment, history of habitual sedative medication and alcoholism will be excluded from this study.

ERCP

20 ASA Class II-III, aged 20-80 adult patients who require moderate sedation during ERCP will be enrolled into this study. The moderate sedation will be performed only after patients' inform consents and approval of the institutional ethics committee. Patients with conditions such as neurological disorders, hearing impairment, history of habitual sedative medication and alcoholism will be excluded from this study.

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ASA Class II-III, aged 20-80 adult patients

You may qualify if:

• ASA Class II-III,
• Aged 20-80 adult patients
• Undergoing moderate sedation during ERCP (endoscopic retrograde cholangiopancreatography) and brochoscopy

You may not qualify if:

• Neurological disorders
• Hearing impairment
• History of habitual sedative medication
• Alcoholism

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: March 24, 2020
• Study Start: March 23, 2020
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: March 24, 2020

Record last verified: 2020-03