Performance of Endoscopic Submucosal Dissection According to the Sedation Method

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.

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Key information

Conditions

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

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Severance Hospital

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

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

Exclusion criteria

Previous subtotal gastrectomy
Previous gastrostomy
Repeated endoscopic submucosal dissection
Three or more synchronous lesions
Allergy to midazolam, propofol, fentanyl, or remifentanil
Pregnancy or breast milk feeding
Active infection
Significant cardiopulmonary disease
Active hepatitis or severe hepatic dysfunction
Severe renal dysfunction
Severe bone marrow dysfunction
Severe neurologic or psychotic disorder

Treatment and study plan

Intermittent midazolam/propofol injection controlled by endoscopist

Procedure

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.

Continuous propofol infusion with opioid administration

Procedure

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.

Primary outcomes

Satisfaction of endoscopists

Time frame: Within 10 minutes from the end of the endoscopic submucosal dissection

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Mar 7, 2013
Registry last updated: Jan 30, 2014

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.

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