Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Application of Response Surface Model on Sedative Procedures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04318457
Recruitment Status : Not yet recruiting
First Posted : March 24, 2020
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan

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

Condition or disease
Anesthesia

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: The Application of Response Surface Model on Sedative Endoscopic Retrograde Cholangiopancreatography and Sedative Bronchoscopy
Estimated Study Start Date : March 23, 2020
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2020

Group/Cohort
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.



Primary Outcome Measures :
  1. Response Surface Models [ Time Frame: 10 seconds from once the anesthetics were terminated to 10 minutes after the time of each patient's wake up ]
    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.

  2. Evaluation of Response Surface Model Predictions [ Time Frame: 10 seconds from once the anesthetics were terminated to 10 minutes after the time of each patient's wake up ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ASA Class II-III, aged 20-80 adult patients
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
Layout table for additonal information
Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT04318457    
Other Study ID Numbers: 2019-01-007BC
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No