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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Early Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology and Pain Medicine

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BIS sensor attachment

Device

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.

no- BIS sensor attachment

Drug

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Aug 13, 2013
Registry last updated: Aug 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed