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Monitored Anesthesia Care With Propofol Plus Remifentanil During Endoscopic Submucosal Dissection: Evaluation of Bispectral Index Monitoring

Not Applicable
Completed
Conditions
Early Gastric Cancer
Interventions
Device: BIS sensor attachment
Drug: 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
Inclusion Criteria
  • American Society of Anesthesiologists (ASA) physical status I to II.
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
BIS groupBIS sensor attachmentThe BIS group (n=90) was monitored for sedation depth using BIS during ESD.
No-BIS groupno- BIS sensor attachmentThe no-BIS group (n=90) was monitored by observer's assessment alertness/sedation scale (OAA/S).
Primary Outcome Measures
NameTimeMethod
procedure satisfaction score of propofol additionan 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
NameTimeMethod

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine

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Seoul, Korea, Republic of

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