ClinicalTrials.Veeva

Menu

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

Samsung Medical Center logo

Samsung Medical Center

Status and phase

Unknown
Phase 3

Conditions

Gastric Cancer
Gastric Adenoma

Treatments

Device: bispectral index monitoring

Study type

Interventional

Funder types

Other

Identifiers

NCT01157598
2009-08-037

Details and patient eligibility

About

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.

Enrollment

56 estimated patients

Sex

All

Ages

19 to 80 years old

Volunteers

No 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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

56 participants in 2 patient groups, including a placebo group

BIS group
Active Comparator group
Treatment:
Device: bispectral index monitoring
non BIS group
Placebo Comparator group
Treatment:
Device: bispectral index monitoring

Trial contacts and locations

1

Loading...

Central trial contact

Ki Joo Kang, Dr; Jae.J Kim, professor

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems