A prospective randomized controlled trial of the usefulness of the bispectral index (BIS) monitor in propofol sedation with double-balloon endoscopic retrograde cholangiopancreatography (DB-ERCP) for postoperative reconstructed intestinal cases
Not Applicable
- Conditions
- patients with postoperative reconstructed intestine who are scheduled to be performed DB-ERCP
- Registration Number
- JPRN-UMIN000037225
- Lead Sponsor
- Okayama University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Not provided
Exclusion Criteria
1)Patients less than 20 years old 2)Pregnant woman 3)Patients with egg, soy, propofol allergy 4)Patients with hypotension (less than 90/50 mmHg) or bradycardia (less than 50bpm), and patients receiving oxygen prior to sedation 5)Patients with ASA-Performance status 4-6 6)Patients already registered in this study 7)Patients who determined to be inappropriate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The body movement occurrence rates in each group
- Secondary Outcome Measures
Name Time Method 1)Occurrence rate of respiratory depression and circulatory failure in each group 2)Inspection interruption rate due to sedation failure in each group 3)Technical success rate in each group 4)Propofol dose in each group 5)Procedure time and anesthesia time in each group 6)Recovery time in each group 7)Risk factors for occurrence of body movement 8)Sedation satisfaction score 9)Adverse events