Performance of Endoscopic Submucosal Dissection According to the Sedation Method

Early Gastric Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01806753
• Other study ID #: 4-2012-0661
• Status: Completed
• Phase: N/A
• First received: March 5, 2013
• Last updated: January 28, 2014
• Start date: March 2013
• Est. completion date: January 2014

Study information

• Verified date: January 2014
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Early Gastric Cancer
• Gastric Adenoma

Intervention

Procedure:
• Intermittent 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.
• Continuous 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.

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Satisfaction of endoscopists		Within 10 minutes from the end of the endoscopic submucosal dissection	Yes