Recruitment

Recruitment Status
Unknown status

Inclusion Criterias

Patients undergone ERCP for biliary and pancreatic diseases
Patients undergone ERCP for biliary and pancreatic diseases

Exclusion Criterias

hypotension (systolic blood pressure <90 mmHg), hypoxemia (SaO2 <90%), or bradycardia (50/min) at baseline measurements
Age under 18 years or over 90 years
Known allergy to midazolam or propofol
...
hypotension (systolic blood pressure <90 mmHg), hypoxemia (SaO2 <90%), or bradycardia (50/min) at baseline measurements
Age under 18 years or over 90 years
Known allergy to midazolam or propofol
Past medication history of benzodiazepine or narcotics
Pregnancy
Comorbid conditions of ASA class 4-5

Summary

Conditions
  • Biliary Tract Diseases
  • Pancreatic Diseases
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Participation Requirements

Age
Between 18 years and 90 years
Gender
Both males and females

Description

The patients undergone ERCP were randomly assigned to either continuous infusion of propofol (continuous group) or midazolam plus intermittent bolus injection of propofol (intermittent group) for deep sedation. In the continuous group, propofol was continuously administered via infusion pump and the...

The patients undergone ERCP were randomly assigned to either continuous infusion of propofol (continuous group) or midazolam plus intermittent bolus injection of propofol (intermittent group) for deep sedation. In the continuous group, propofol was continuously administered via infusion pump and the doses were determined by sedation assistants monitoring the patients. In the intermittent group, a loading dose of 2 mg of midazolam and 0.4 mg/kg of propofol was initially injected and repeated bolus injection of 20 mg of propofol was followed according to patients' sedation level. Sedation related parameters (total dose of propofol, induction/recovery time, patients' cooperation) and adverse events during the procedure were evaluated. Satisfaction scores by endoscopist, assistant, and patients and difficulty scores of maintaining the sedation by assistants were also graded after the procedure.

Inclusion Criterias

Patients undergone ERCP for biliary and pancreatic diseases
Patients undergone ERCP for biliary and pancreatic diseases

Exclusion Criterias

hypotension (systolic blood pressure <90 mmHg), hypoxemia (SaO2 <90%), or bradycardia (50/min) at baseline measurements
Age under 18 years or over 90 years
Known allergy to midazolam or propofol
...
hypotension (systolic blood pressure <90 mmHg), hypoxemia (SaO2 <90%), or bradycardia (50/min) at baseline measurements
Age under 18 years or over 90 years
Known allergy to midazolam or propofol
Past medication history of benzodiazepine or narcotics
Pregnancy
Comorbid conditions of ASA class 4-5

Locations

Guri, Gyeonggi, 471-701
Guri, Gyeonggi, 471-701

Tracking Information

NCT #
NCT01900938
Collaborators
Not Provided
Investigators
  • Principal Investigator: Kyo-Sang Yoo Hanyang University
  • Kyo-Sang Yoo Hanyang University