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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

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 - 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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000037225
Enrollment
100
Registered
2019-07-01
Start date
2019-08-20
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients with postoperative reconstructed intestine who are scheduled to be performed DB-ERCP

Interventions

Using BIS monitor, consider BIS value: 40-60 as appropriate sedation level and adjust the target blood concentration of propofol. Do not use BIS monitor, consider Ramsey Sedation Score: SS 5-6 as the

Sponsors

Okayama University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: patients with postoperative reconstructed intestine who are scheduled to be performed DB-ERCP

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
The body movement occurrence rates in each group

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactKazuya Miyamoto

Okayama University Hospital Department of Gastroenterology and Hepatology

ttpcx442@yahoo.co.jp086-235-7219

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026