Early Gastric Cancer, Gastric Adenoma
Conditions
Keywords
Endoscopic submucosal dissection, Sedation, Propofol, Midazolam
Brief summary
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.
Interventions
PROCEDUREIntermittent midazolam/propofol injection controlled by endoscopist
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.
PROCEDUREContinuous propofol infusion with opioid administration
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.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age, between 20 and 80 2. Early gastric cancer or adenoma, which is indicated by endoscopic submucosal dissection 3. ECOG performance status 0 or 1 4. American Society of Anesthesiologist Physical Status 1, 2, or 3
Exclusion criteria
1. Previous subtotal gastrectomy 2. Previous gastrostomy 3. Repeated endoscopic submucosal dissection 4. Three or more synchronous lesions 5. Allergy to midazolam, propofol, fentanyl, or remifentanil 6. Pregnancy or breast milk feeding 7. Active infection 8. Significant cardiopulmonary disease 9. Active hepatitis or severe hepatic dysfunction 10. Severe renal dysfunction 11. Severe bone marrow dysfunction 12. Severe neurologic or psychotic disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Satisfaction of endoscopists | Within 10 minutes from the end of the endoscopic submucosal dissection |
Countries
South Korea
Outcome results
None listed