The Application of Response Surface Model on Sedative Procedures

NCT ID: NCT04318457

Last Updated: 2020-03-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-23
• Study Completion Date: 2020-07-31

Brief Summary

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

Detailed Description

It is very important to understand the influence of drug interactions of patients in clinical anesthesia. However, there were only a few quantitative studies on the pharmacodynamics of different drug combinations and patient responses. In recent years, the investigators have innovatively utilized the response surface models in patients receiving painless gastro-intestinal endoscopies. Appropriate pharmacodynamic models of clinical anesthesia for these procedures provide observation, evaluation, and prediction of the pharmacodynamic effects of a combination of clinical anesthetics to such patients. Patients with endoscopic retrograde cholangiopancreatography (ERCP) and bronchoscopy often have a need for painless service, but current clinical studies of using a pharmacodynamic model were lacking in these patients. The investigators therefore design a two-year prospective, observational project to investigate the optimal drug concentration combinations for the shortest wake-up time, adequate analgesia, and appropriate depth of anesthesia for sedative endoscopic ERCP and sedative bronchoscopy using pharmacodynamic models. Multidimensional surface charting will be performed by inputting diversified parameters to predict the drug interactions of the model groups. In this prospective, observational study, the investigators plan to enroll 40 ASA Class Forty ASA Class II-III, aged 20-80 adult patients who require sedative ERCP and bronchoscopy. Moderate to heavy sedation will be performed only after patients' inform consents and approval of the institutional ethics committee. The investigators plan to complete this series of studies within two years: The first year: ERCP(10 patients) and broncoscopy (10 patients). The second year: ERCP(10 patients) and broncoscopy (10 patients). Using response surface models, this study will offer us novel information about patients during procedures which may substantially increase the anesthesia quality and outcome of sedative ERCP and broncoscopy. Physiological signals such as anesthesia depth, drug concentrations and dosages, alertness/sedation score, heart rate, blood pressure, peripheral oxygen saturation, and physical activity responses during painless procedures will be collected and then the above data will be applied to the response surface models. Then the investigators will find the most appropriate anesthetic response surface which may delineate the effects of drug combinations, and will further improve the anesthesia safety and quality for painless ERCP and bronchoscopy patients.

Conditions

Anesthesia

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2019-01-007BC

Identifier Type: -

Identifier Source: org_study_id