Comparison Between Continuous Infusion and Intermittent Bolus Injection of Propofol for Deep Sedation During ERCP

Hanyang University

Status: Unknown

Conditions: Pancreatic Diseases; Biliary Tract Diseases

Treatments: Procedure: Continuous infusion of propofol; Procedure: Intermittent bolus injection of propofol; Drug: Propofol; Drug: Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT01900938

2012-055

Details and patient eligibility

About

The aim of this study is to compare sedation efficiency, safety and satisfaction by both endoscopist, assistants, and the patients between continuous infusion and intermittent bolus injection of propofol for deep sedation during ERCP.

Full 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 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.

Enrollment: 210 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergone ERCP for biliary and pancreatic diseases

Exclusion criteria

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

Trial design

210 participants in 2 patient groups

Intermittent bolus injection of propofol

Active Comparator group

Description:

A loading dose of 2 mg of midazolam and 0.4 mg/kg of propofol is initially injected and then repeated intermittent bolus injection of 20 mg of propofol is followed according to patients' sedation level.

Treatment:

Procedure: Intermittent bolus injection of propofol

Drug: Midazolam

Drug: Propofol

Continuous infusion of propofol

Active Comparator group

Description:

Propofol is continuously administered intravenously via infusion pump starting with 20 mg/kg/hr and then titrated to about 5 mg/kg/hr according to patients' sedation level.

Treatment:

Drug: Propofol

Procedure: Continuous infusion of propofol