Performance of Endoscopic Submucosal Dissection According to the Sedation Method

January 28, 2014 updated by: Yonsei University
Although proper sedation is mandatory for endoscopic procedures such as endoscopic submucosal dissection, the effects of sedation on ESD performance and complications have not been fully evaluated. In the investigators previous retrospective study, en bloc resection and complete resection rates, and procedure time could be improved by sedation with continuous propofol infusion with opioid administration by anesthesiologists. However, there are several limitations to the study including retrospective design. The investigators aimed to evaluate the relationship among sedation methods, satisfaction of endoscopists or patients, clinical outcomes, and complications after endoscopic submucosal dissection for gastric neoplasia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

157

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age, between 20 and 80
  2. Early gastric cancer or adenoma, which is indicated by endoscopic submucosal dissection
  3. ECOG performance status 0 or 1
  4. American Society of Anesthesiologist Physical Status 1, 2, or 3

Exclusion Criteria:

  1. Previous subtotal gastrectomy
  2. Previous gastrostomy
  3. Repeated endoscopic submucosal dissection
  4. Three or more synchronous lesions
  5. Allergy to midazolam, propofol, fentanyl, or remifentanil
  6. Pregnancy or breast milk feeding
  7. Active infection
  8. Significant cardiopulmonary disease
  9. Active hepatitis or severe hepatic dysfunction
  10. Severe renal dysfunction
  11. Severe bone marrow dysfunction
  12. Severe neurologic or psychotic disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: midazolam/propofol injection
Intermittent midazolam/propofol injection controlled by endoscopist
Procedure: Intermittent midazolam/propofol injection controlled by endoscopist

In this arm1, sedation during endoscopic submucosal dissection is controlled by endoscopists.

First, pethidine 50 mg with midazolam 0.05 mg/kg are injected in a bolus fashion.

When the patient seems to be discomfort or the patient's movements were observed, endoscopists should check the Modified Observer Assessment of Alertness/Sedation (MOAAS).

If MOAAS is 5 or 6, propofol 0.25 mg/kg will be injected. Otherwise, pethidine 12.5 mg will be injected.
Active Comparator: propofol infusion
Continuous propofol infusion with opioid administration
Procedure: Continuous propofol infusion with opioid administration

In this arm2, sedation during endoscopic submucosal dissection is controlled by anesthesiologists.

First, remifentanil 0.5 ug/kg with propofol 0.5 mg/kg are injected in a bolus fashion.

Then, remifentanil 0.08 ug/kg/min and propofol 2 mg/kg/h are infused continuously.

When the patient seems to be discomfort or the patient's movements were observed, anesthesiologists should check the MOAAS.

If MOAAS is 5 or 6, infusion rate of propofol will be increased by 0.5 mg/kg/h. Otherwise, infusion rate of remifentanil will be increased by 0.02 ug/kg/min.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Satisfaction of endoscopists
Time Frame: Within 10 minutes from the end of the endoscopic submucosal dissection
Within 10 minutes from the end of the endoscopic submucosal dissection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

March 5, 2013

First Submitted That Met QC Criteria

March 6, 2013

First Posted (Estimate)

March 7, 2013

Study Record Updates

Last Update Posted (Estimate)

January 30, 2014

Last Update Submitted That Met QC Criteria

January 28, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2012-0661

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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