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Efficacy of Bispectral Index Monitoring for Midazolam and Meperidine Induced Sedation During Endoscopic Submucosal Dissection

Primary Purpose

Gastric Adenoma, Gastric Cancer

Status

Unknown status

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

bispectral index monitoring

About this trial

This is an interventional supportive care trial for Gastric Adenoma focused on measuring gastric adenoma, early gastric cancer

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

gastric adenomas, differentiated-type gastric cancers greater than 30 mm in diameter without ulceration and gastric cancers up to 30 mm with ulceration, or minute submucosal invasion

Exclusion Criteria:

if they were under 18 years of age
had an ASA classification of 4-5
were pregnant
had a history of stroke or an allergy to sedative drugs.

Sites / Locations

Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

BIS group

non BIS group

Arm Description

Outcomes

Primary Outcome Measures

the satisfaction of patients and endoscopist in midazolam and meperidine induced sedation with BIS monitoring during ESD

Secondary Outcome Measures

the dose of midazolam and meperidine during ESD with BIS monitoring

Full Information

NCT ID

NCT01157598

First Posted

July 5, 2010

Last Updated

July 6, 2010

Sponsor

Samsung Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01157598

Brief Title

Efficacy of Bispectral Index Monitoring for Midazolam and Meperidine Induced Sedation During Endoscopic Submucosal Dissection

Official Title

Efficacy of Bispectral Index Monitoring for Midazolam and Meperidine Induced Sedation During Endoscopic Submucosal Dissection

Study Type

Interventional

2. Study Status

Record Verification Date

July 2010

Overall Recruitment Status

Unknown status

Study Start Date

September 2009 (undefined)

Primary Completion Date

September 2010 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Samsung Medical Center

4. Oversight

5. Study Description

Brief Summary

Background: Endoscopic submucosal dissection (ESD) usually requires adequate level of sedation due to lengthy and uncomfortable procedure. Propofol induced sedation with bispectral index (BIS) monitoring has been reported to lead to higher satisfaction of patients and endoscopists during ESD. However, there is no data about efficacy of midazolam and meperidine induced sedation with BIS monitoring during ESD. This study was to evaluate whether midazolam and meperidine induced sedation with BIS monitoring could improve the satisfaction and reduce the dose of midazolam and meperidine during ESD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Adenoma, Gastric Cancer

Keywords

gastric adenoma, early gastric cancer

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

BIS group

Arm Type

Active Comparator

Arm Title

non BIS group

Arm Type

Placebo Comparator

Intervention Type

Device

Intervention Name(s)

bispectral index monitoring

Intervention Description

parameter monitoring of bispectral index

Primary Outcome Measure Information:

Title

the satisfaction of patients and endoscopist in midazolam and meperidine induced sedation with BIS monitoring during ESD

Time Frame

within the one day after ESD

Secondary Outcome Measure Information:

Title

the dose of midazolam and meperidine during ESD with BIS monitoring

Time Frame

within one hour after ESD

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: gastric adenomas, differentiated-type gastric cancers greater than 30 mm in diameter without ulceration and gastric cancers up to 30 mm with ulceration, or minute submucosal invasion Exclusion Criteria: if they were under 18 years of age had an ASA classification of 4-5 were pregnant had a history of stroke or an allergy to sedative drugs.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jae.J Kim, professor

Phone

+82-2-3410-3409

jjkim@skku.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Ki Joo Kang, Dr

Phone

+82-2-3410-3409

kj74.kang@samsung.com

Facility Information:

Facility Name

Samsung Medical Center

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

JaeJ Kim, professor

Phone

+82-2-3410-3409

jjkim@skku.edu

First Name & Middle Initial & Last Name & Degree

JaeJ Kim, professor

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Bispectral Index Monitoring for Midazolam and Meperidine Induced Sedation During Endoscopic Submucosal Dissection

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