Early Gastric Cancer
Conditions
Keywords
propofol, endoscopy, bispectral index
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.
Interventions
DEVICEBIS 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.
DRUGno- BIS sensor attachment
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Outcome results
None listed