Performance of Endoscopic Submucosal Dissection According to the Sedation Method

NACompletedINTERVENTIONAL
Enrollment

157

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

January 31, 2014

Study Completion Date

January 31, 2014

Conditions
Early Gastric CancerGastric Adenoma
Interventions
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."

Trial Locations (1)

120-752

Severance Hospital, Seoul

All Listed Sponsors
lead

Yonsei University

OTHER

NCT01806753 - Performance of Endoscopic Submucosal Dissection According to the Sedation Method | Biotech Hunter | Biotech Hunter