CO2 Versus O2 Insufflation During ERCP Depending on Sedation Protocols

Study Overview
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Brief Summary
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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.

Official Title
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Carbon Dioxide Insufflations vs. Air Insufflation in Therapeutic ERCP: A Randomized Double-blind Comparative Study Depending on Sedation Methods

Conditions
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Satisfaction, Complication

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1. Carbon dioxide insufflation with BPS<br>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<br>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<br>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<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sedation quality | Abdominal pain, discomfort, and gas accumulation | After patients' alertness (at least 10 minutes later), 3 hrs, and 24 hrs later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Procedure related complications; pancreatitis, bleeding, cholangitis, or perforation | After completion of procedures (within 2 hrs) and 24 hrs later | 
| Procedure outcome | Technical success or fail of procedure Procedure quality and satisfaction to patients and endoscopist | After completion of procedure, within 2hrs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carbon dioxide insufflation, Air insufflatioin, ERCP, Sedation