Monitored Anesthesia Care With Propofol Plus Remifentanil During Endoscopic Submucosal Dissection: Evaluation of Bispectral Index Monitoring
- Conditions
- Early Gastric Cancer
- Interventions
- Device: BIS sensor attachmentDrug: no- BIS sensor attachment
- Registration Number
- NCT01921283
- Lead Sponsor
- Yonsei University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 180
- American Society of Anesthesiologists (ASA) physical status I to II.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BIS group BIS sensor attachment The BIS group (n=90) was monitored for sedation depth using BIS during ESD. No-BIS group no- BIS sensor attachment The no-BIS group (n=90) was monitored by observer's assessment alertness/sedation scale (OAA/S).
- Primary Outcome Measures
Name Time Method procedure satisfaction score of propofol addition 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Anesthesiology and Pain Medicine
🇰🇷Seoul, Korea, Republic of