Monitored Anesthesia Care With Propofol Plus Remifentanil During Endoscopic Submucosal Dissection: Evaluation of Bispectral Index Monitoring
Overview
- Phase
- Not Applicable
- Intervention
- BIS sensor attachment
- Conditions
- Early Gastric Cancer
- Sponsor
- Yonsei University
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- procedure satisfaction score of propofol addition
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
There are clinical usefulness issues associated with bispectral index (BIS) for sedation of endoscopic submucosal dissection (ESD). However, the clinical usefulness of BIS for deep sedation is incompletely described. The purpose of this study is to show that BIS-guided sedation is safe and useful clinically and may provide stable sedation status to physicians and patients.
Investigators
Eligibility Criteria
Inclusion Criteria
- •American Society of Anesthesiologists (ASA) physical status I to II.
Exclusion Criteria
- •body mass index (BMI) over 35 (Kg/m2)
- •hepatic or renal insufficiency
- •history of allergy to the drugs used
- •history of administration of anxiolytics, narcotics, antipsychotics, opioid.
Arms & Interventions
BIS group
The BIS group (n=90) was monitored for sedation depth using BIS during ESD.
Intervention: BIS sensor attachment
No-BIS group
The no-BIS group (n=90) was monitored by observer's assessment alertness/sedation scale (OAA/S).
Intervention: no- BIS sensor attachment
Outcomes
Primary Outcomes
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.