Performance of Endoscopic Submucosal Dissection According to the Sedation Method

Study Overview
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Brief Summary
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Although proper sedation is mandatory for endoscopic procedures such as endoscopic submucosal dissection, the effects of sedation on ESD performance and complications have not been fully evaluated. In the investigators previous retrospective study, en bloc resection and complete resection rates, and procedure time could be improved by sedation with continuous propofol infusion with opioid administration by anesthesiologists. However, there are several limitations to the study including retrospective design. The investigators aimed to evaluate the relationship among sedation methods, satisfaction of endoscopists or patients, clinical outcomes, and complications after endoscopic submucosal dissection for gastric neoplasia.

Conditions
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Early Gastric Cancer, Gastric Adenoma

Intervention / Treatment
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* Procedure: Intermittent midazolam/propofol injection controlled by endoscopist
* Procedure: Continuous propofol infusion with opioid administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age, between 20 and 80 Early gastric cancer or adenoma, which is indicated by endoscopic submucosal dissection ECOG performance status 0 or 1 American Society of Anesthesiologist Physical Status 1, 2, or 3 Exclusion Criteria: Previous subtotal gastrectomy Previous gastrostomy Repeated endoscopic submucosal dissection Three or more synchronous lesions Allergy to midazolam, propofol, fentanyl, or remifentanil Pregnancy or breast milk feeding Active infection Significant cardiopulmonary disease Active hepatitis or severe hepatic dysfunction Severe renal dysfunction Severe bone marrow dysfunction Severe neurologic or psychotic disorder

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: midazolam/propofol injection<br>Intermittent midazolam/propofol injection controlled by endoscopist | Procedure: Intermittent midazolam/propofol injection controlled by endoscopist<br>* In this arm1, sedation during endoscopic submucosal dissection is controlled by endoscopists. First, pethidine 50 mg with midazolam 0.05 mg/kg are injected in a bolus fashion. When the patient seems to be discomfort or the patient's movements were observed, endoscopists should check the Modified Observer Assessment of Alertness/Sedation (MOAAS). If MOAAS is 5 or 6, propofol 0.25 mg/kg will be injected. Otherwise, pethidine 12.5 mg will be injected.<br>|
| Active Comparator: propofol infusion<br>Continuous propofol infusion with opioid administration | Procedure: Continuous propofol infusion with opioid administration<br>* In this arm2, sedation during endoscopic submucosal dissection is controlled by anesthesiologists. First, remifentanil 0.5 ug/kg with propofol 0.5 mg/kg are injected in a bolus fashion. Then, remifentanil 0.08 ug/kg/min and propofol 2 mg/kg/h are infused continuously. When the patient seems to be discomfort or the patient's movements were observed, anesthesiologists should check the MOAAS. If MOAAS is 5 or 6, infusion rate of propofol will be increased by 0.5 mg/kg/h. Otherwise, infusion rate of remifentanil will be increased by 0.02 ug/kg/min.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction of endoscopists |  | Within 10 minutes from the end of the endoscopic submucosal dissection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopic submucosal dissection, Sedation, Propofol, Midazolam