NCT01806753

Performance of Endoscopic Submucosal Dissection According to the Sedation Method

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 157 (actual)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Early Gastric Cancer
• Gastric Adenoma

Interventions

Type	Name	Description
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.
PROCEDURE	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.

Timeline

• Start date: 2013-03-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2013-03-07
• Last updated: 2014-01-30

Locations

1 site across 1 country: South Korea