Monitored Anesthesia Care With Propofol Plus Remifentanil During Endoscopic Submucosal Dissection: Evaluation of Bispectral Index Monitoring
|ClinicalTrials.gov Identifier: NCT01921283|
Recruitment Status : Completed
First Posted : August 13, 2013
Last Update Posted : August 13, 2013
|Condition or disease||Intervention/treatment||Phase|
|Early Gastric Cancer||Device: BIS sensor attachment Drug: no- BIS sensor attachment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Supportive Care|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
Experimental: BIS group
The BIS group (n=90) was monitored for sedation depth using BIS during ESD.
Device: BIS sensor attachment
For double blind method, BIS sensors were attached to all patients, but only BIS-group was measured by the value. BIS monitor was pushed back toward the anesthesiologist so that the physician could not see it. 3 L/min of oxygen was delivered by a nasal cannula to all patients throughout the procedure. Blood pressure was recorded every 5 minutes and heart rate, peripheral oxygen saturation were measured continuously. For induction of sedation, propofol 1 mg/Kg and lidocaine 30mg was administered throughout IV line and immediately followed by continuous infusion of propofol 0.04-0.06 mg/Kg/min and remifentanil 0.05 mcg/Kg/min. The evaluation of sedation depth using OAA/S was performed at 1 minute after propofol administration, endoscopy insertion, submucosal inflation by 1:100000 epinephrine with indigocarmine, initial submucosal dissection and when the patient had restlessness or coughing additively.
Active Comparator: No-BIS group
The no-BIS group (n=90) was monitored by observer's assessment alertness/sedation scale (OAA/S).
Drug: no- BIS sensor attachment
- procedure satisfaction score of propofol addition [ Time Frame: an average time for 1 week from propofol addition ]The evaluation of sedation depth using OAA/S will be performed at 1 minute after propofol administration, endoscopy insertion, submucosal inflation by 1:100000 epinephrine with indigocarmine, initial submucosal dissection and when the patient have restlessness or coughing additively.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01921283
|Korea, Republic of|
|Department of Anesthesiology and Pain Medicine|
|Seoul, Korea, Republic of, 120-752|