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Performance of Endoscopic Submucosal Dissection According to the Sedation Method

Primary Purpose

Early Gastric Cancer, Gastric Adenoma

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Intermittent midazolam/propofol injection controlled by endoscopist

Continuous propofol infusion with opioid administration

About this trial

This is an interventional treatment trial for Early Gastric Cancer focused on measuring Endoscopic submucosal dissection, Sedation, Propofol, Midazolam

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

midazolam/propofol injection

propofol infusion

Arm Description

Intermittent midazolam/propofol injection controlled by endoscopist

Continuous propofol infusion with opioid administration

Outcomes

Primary Outcome Measures

Satisfaction of endoscopists

Secondary Outcome Measures

Full Information

NCT ID

NCT01806753

First Posted

March 5, 2013

Last Updated

January 28, 2014

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT01806753

Brief Title

Performance of Endoscopic Submucosal Dissection According to the Sedation Method

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

March 2013 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Early Gastric Cancer, Gastric Adenoma

Keywords

Endoscopic submucosal dissection, Sedation, Propofol, Midazolam

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

157 (Actual)

8. Arms, Groups, and Interventions

Arm Title

midazolam/propofol injection

Arm Type

Experimental

Arm Description

Intermittent midazolam/propofol injection controlled by endoscopist

Arm Title

propofol infusion

Arm Type

Active Comparator

Arm Description

Continuous propofol infusion with opioid administration

Intervention Type

Procedure

Intervention Name(s)

Intermittent midazolam/propofol injection controlled by endoscopist

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Continuous propofol infusion with opioid administration

Intervention Description

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 Outcome Measure Information:

Title

Satisfaction of endoscopists

Time Frame

Within 10 minutes from the end of the endoscopic submucosal dissection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Severance Hospital

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

25803441

Citation

Park CH, Shin S, Lee SK, Lee H, Lee YC, Park JC, Yoo YC. Assessing the stability and safety of procedure during endoscopic submucosal dissection according to sedation methods: a randomized trial. PLoS One. 2015 Mar 24;10(3):e0120529. doi: 10.1371/journal.pone.0120529. eCollection 2015. Erratum In: PLoS One. 2015;10(4):e0127473.

Results Reference

derived

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Performance of Endoscopic Submucosal Dissection According to the Sedation Method

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