NIPH Clinical Trials Search

JRCT ID: jRCTs041180164

Registered date:29/03/2019

The usefulness and Safety of propofol for benzodiazepine resistance cases in endoscopic sedation

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedA patient who is scheduled to receive endoscopic examination / treatment at the Kanazawa University
Date of first enrollment01/05/2015
Target sample size120
Countries of recruitment
Study typeInterventional
Intervention(s)Even if benzodiazepine derivative (midazolam 10 mg) is used, sufficient sedation Propofol is intravenously injected at 0.5 mg / kg to a patient who can not obtain it and needs to be stopped by a caregiver, and it is added as necessary as needed until sufficient sedation is obtained with body movement etc. as an index.


Primary OutcomeAdverse events (safety) that occurred before and after using propofol It is necessary to evaluate adverse events due to propofol addition and evaluate the risk by adding it.
Secondary Outcome1) Changes in vital signs before and after using propofol (safety) Reduction in blood pressure, decrease in pulse rate, decrease in SpO 2, as a result of addition of propofol It is thoughtful and needs to be evaluated. 2) Change in BIS value before and after use of propofol (efficacy) This study is a proposal for benzodiazepine derivative resistance in sedation The purpose of this study is to examine the usefulness of this system. The depth of anesthesia is most objectively The BIS value expressed is considered to indicate the utility of propofol in the most detail. 3) Change in RASS before and after use of propofol (efficacy) In addition to the BIS value, it is evaluated as the evaluation standard of the depth of anesthesia. 4) Number of people (effectiveness) required to suppress patients before and after using propofol By using propofol, objectively indicate whether the necessary manpower will decrease. 5) Total Propofol Total Cost and Cost It is also necessary to evaluate the cost of adding propofol.

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
Include criteria1 We will undergo endoscopic examination / treatment that requires sedation. Endoscopic examination / treatment requiring sedation is, ESD (Endoscopic Submucosal Dissection, endoscopic mucosa Underlying exfoliation) ERCP (Endoscopic retrograde cholangiopancreatography, Endoscopic retrograde cholangiopancreatography and pancreatic duct) Related procedures Endoscopic esophagus, treatment of gastric varices (EIS (Endoscopic injection sclerotherapy, Endoscopic varicose sclerotherapy), EVL (Endoscopic variceal ligation Endoscopic varicose ligation ligation)) EUS-FNA (Endoscopic Ultrasound-Fine Needle Aspiration; Ultrasonic endoscopic puncture suction method) DBE (double ballon endoscopy) 2 The age of registration is over 20 years old. 3 ECOG-Performance Status is 0 or 1. 4 liver / renal function is maintained. AST less than 100 IU /, ALT less than 100 IU / Serum creatinine less than 2.0 mg / dL. 5 There are no contraindications to propofol. 6 For patient participation, written consent has been obtained from the patient himself. 7 Sufficient sedation even when benzodiazepine derivative (midazolam 10 mg) is used It is impossible to obtain it, but it is necessary to stop by a caretaker.
Exclude criteria1 for propofol or propofol 1% intravenous components I have a history of hypersensitivity. 2 During pregnancy and lactation. 3 ECOG-Performance Status is 2 or more. 4 Propofol can not be used due to hepatic / renal dysfunction. 5 In addition, it is judged that the doctor in charge is inappropriate for carrying out this examination.

Related Information


Public contact
Name Tomoyuki Hayashi
Address Takaramachi 13-1, Kanazawa, Ishikawa, Japan Ishikawa Japan 920-8641
Telephone +81-76-265-2235
Affiliation Kanazawa University
Scientific contact
Name Shuichi Kaneko
Address Takaramachi 13-1, Kanazawa, Ishikawa, Japan Ishikawa Japan 920-8641
Telephone +81-76-265-2235
Affiliation Kanazawa University