Prospectiv, single-center trial to evaluate the rate of of hypoxaemia and hypotension in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) with sedation.

Prospectiv, single-center trial to evaluate the rate of of hypoxaemia and hypotension in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) with sedation. - DoubleHypoERCP

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00005201

Enrollment

200

Registered

2014-02-19

Start date

2014-03-04

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

K83.0 K76.9

Interventions

Group 1: Detection of sedation relateted complication if sedation administreded by anaesthesia personal in patients undergoing ERCP procedure.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age: 18 years and older, patients undergoing endoscopic retrograde cholangiopancreatography

Exclusion criteria

Exclusion criteria: impaired mental state or language problem, patients with known allergy to propofol and/ or remifentanyl, need of general anaesthesia, pregnancy, oxygen saturation lower than 90% befor interventation, bloodpressure lower than 90 mmHg bevor intervention

Design outcomes

Primary

Measure	Time frame
Rate of hypoxaemia (oxygen saturation lower than 90%) and hypotension (bloodpressure lower than 90 mmHg) during sedation. Oxygen saturation will be measured continously and blood pressure will be measured every five minutes.	—

Secondary

Measure	Time frame
Failure to complete the procedure due to sedation-related problems documented at Case Fall Report (CFR) satisfaction of patient: Likert-scale after the examination bevor leaving the recovery area satisfaction of examine Likert-scale after the examination willingness to repeat procedure in the same conditions after the examination bevor leaving the recovery area, rate of intubation of papille vateri documented at Case Fall Report (CFR) during the examination heart rate documented every 5 minutes at Case Fall Report (CFR) during the examination BIS-Index documented every 5 minutes at Case Fall Report (CFR) after the examination endtidale CO2 documented every 5 minutes at Case Fall Report (CFR) after the examination rate of successful ERCP documented at CFR after the examination duration of ERCP documented in minutes at CFR after the examination cumulated dose of propofol documented at CFR after the examination cumulated dose of remifentanil documented at CFR after the examination recovery time documented at CFR bevor leaving the recovery area mortality (30 days) documentes at seperate sheet	—

Measure

Time frame

Failure to complete the procedure due to sedation-related problems documented at Case Fall Report (CFR) satisfaction of patient: Likert-scale after the examination bevor leaving the recovery area satisfaction of examine Likert-scale after the examination willingness to repeat procedure in the same conditions after the examination bevor leaving the recovery area, rate of intubation of papille vateri documented at Case Fall Report (CFR) during the examination heart rate documented every 5 minutes at Case Fall Report (CFR) during the examination BIS-Index documented every 5 minutes at Case Fall Report (CFR) after the examination endtidale CO2 documented every 5 minutes at Case Fall Report (CFR) after the examination rate of successful ERCP documented at CFR after the examination duration of ERCP documented in minutes at CFR after the examination cumulated dose of propofol documented at CFR after the examination cumulated dose of remifentanil documented at CFR after the examination recovery time documented at CFR bevor leaving the recovery area mortality (30 days) documentes at seperate sheet

—

Countries

Germany

Contacts

Public ContactNicole Ganion

Klinik für AnästhesiologieUniklinik Heidelberg

Nicole.Ganion@med.uni-heidelberg.de06221/56-36154

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026