Performance of Endoscopic Submucosal Dissection According to the Sedation Method

NCT ID: NCT01806753

Last Updated: 2014-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 157 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-01-31

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.

Conditions

Early Gastric Cancer; Gastric Adenoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

midazolam/propofol injection

Intermittent midazolam/propofol injection controlled by endoscopist

Group Type: EXPERIMENTAL

Intermittent midazolam/propofol injection controlled by endoscopist

Intervention Type: 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.

propofol infusion

Continuous propofol infusion with opioid administration

Group Type: ACTIVE_COMPARATOR

Continuous propofol infusion with opioid administration

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Severance Hospital

Seoul, Seoul, South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 25803441 (View on PubMed)

Other Identifiers

4-2012-0661

Identifier Type: -

Identifier Source: org_study_id