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

JRCT ID: jRCTs041180164

Registered date:29/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: A patient who is scheduled to receive endoscopic examination / treatment at the Kanazawa University
• Date of first enrollment: 01/05/2015
• Target sample size: 120
• Study type: Interventional

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.

Outcome(s)

Primary Outcome

Adverse 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 Outcome

1) 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 maximum: Not applicable
• Gender: Both

Include criteria

1 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 criteria

1 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

• Primary Sponsor: Kaneko Shuichi