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

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ClinicalTrials.gov Identifier: NCT01921283
Recruitment Status : Completed
First Posted : August 13, 2013
Last Update Posted : August 13, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Early Gastric Cancer Device: BIS sensor attachment Drug: no- BIS sensor attachment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
Drug Information available for: Propofol

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01921283


Locations
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Korea, Republic of
Department of Anesthesiology and Pain Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University

Publications:

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01921283     History of Changes
Other Study ID Numbers: 4-2011-0347
First Posted: August 13, 2013    Key Record Dates
Last Update Posted: August 13, 2013
Last Verified: August 2013

Keywords provided by Yonsei University:
propofol, endoscopy, bispectral index

Additional relevant MeSH terms:
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Propofol
Remifentanil
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents