Efficacy of Bispectral Index Monitoring for Midazolam and... | NCT01157598

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

NCT01157598

Sponsor

Samsung Medical Center

Status

Unknown status

Last Update Posted

Jul 7, 2010Estimated

Enrollment

56Estimated

Phase

Phase 3

Conditions

Gastric Adenoma
Gastric Cancer

Interventions

bispectral index monitoring

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Sep 2010Estimated

Completion Date

Not provided

First Submitted Date

Jul 5, 2010

First Submission Date that Met QC Criteria

Jul 6, 2010

First Posted Date

Jul 7, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 6, 2010

Last Update Posted Date

Jul 7, 2010Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

56Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BIS group	Active Comparator		Device: bispectral index monitoring
non BIS group	Placebo Comparator		Device: bispectral index monitoring

Interventions

Name	Type	Description	Arm Group Labels	Other Names
bispectral index monitoring	Device	parameter monitoring of bispectral index	BIS group non BIS group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the satisfaction of patients and endoscopist in midazolam and meperidine induced sedation with BIS monitoring during ESD		within the one day after ESD

Secondary Outcomes

Measure	Description	Time Frame
the dose of midazolam and meperidine during ESD with BIS monitoring		within one hour after ESD

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jae.J Kim, professor	Contact	+82-2-3410-3409		jjkim@skku.edu
Ki Joo Kang, Dr	Contact	+82-2-3410-3409		kj74.kang@samsung.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center	Recruiting	Seoul		135-710	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D013274	Stomach Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided