CO2 Versus O2 Insufflation During ERCP Depending on Sedation Protocols

Soon Chun Hyang University

Status: Completed

Conditions: Complication; Satisfaction

Study type: Observational

Funder types: Other

Identifiers

NCT01761474

ERCP-Sedation

Details and patient eligibility

About

Endoscopic retrograde cholangiopancreatography(ERCP) and related procedures can cause abdominal pain and discomfort. Some clinical trials have indicated, using the visual analogue scale (VAS) score, that CO2 insufflation during ERCP ameliorates the suffering of patients without complications, compared with air insufflation. However, differences in patient suffering between CO2 and air insufflation after ERCP depending on sedation protocols have not been reported. We therefore planned prospective, double-blind, randomized, controlled study with CO2 and air insufflation during ERCP depending on sedation protocol.

Enrollment: 210 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• candidates for therapeutic ERCP

Exclusion criteria

• age<18 years
• pregnant women
• total gastrectomy
• uncontrolled coagulopathy
• American Society of Anesthesiologist(ASA) Class V
• neurologic impairment
• known allergy to the drugs used
• history of complications with previous sedation, sedative
• alcohol abuse
• inability to provide informed consent

Trial design

210 participants in 4 patient groups

1. Carbon dioxide insufflation with BPS

Description:

Both midazolam (0.05 mg/kg body weight; 1 mg if age\[70 or ASA class III-IV) and fentanyl (50 lg; 25 lg if age\[70 or ASA class III-IV) were given intravenously at the initiation of sedation. Thereafter, repeated doses of 10-20 mg propofol were administered to achieve a moderate level of sedation. Maintenance of sedation was also performed with repeated doses of 10-20 mg propofol.

2. Carbon dioxide insufflation with Propofol

Description:

Sedation was induced by intravenous bolus injection of propofol (0.5 mg/kg body weight; 10 mg if age\[70 or ASA class III-IV), followed by repeated doses of 10-20 mg propofol to induce sedation. Repeated doses of 10-20 mg propofol were then administered to maintain adequate sedation, according to the desired sedation depth and patient risk profile.

3. Air insufflation with BPS

Description:

Both midazolam (0.05 mg/kg body weight; 1 mg if age\[70 or ASA class III-IV) and fentanyl (50 lg; 25 lg if age\[70 or ASA class III-IV) were given intravenously at the initiation of sedation. Thereafter, repeated doses of 10-20 mg propofol were administered to achieve a moderate level of sedation. Maintenance of sedation was also performed with repeated doses of 10-20 mg propofol.

4. Air insufflation with Propofol

Description:

Sedation was induced by intravenous bolus injection of propofol (0.5 mg/kg body weight; 10 mg if age\[70 or ASA class III-IV), followed by repeated doses of 10-20 mg propofol to induce sedation. Repeated doses of 10-20 mg propofol were then administered to maintain adequate sedation, according to the desired sedation depth and patient risk profile.