NCT01806753

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
157

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 7, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

January 30, 2014

Status Verified

January 1, 2014

Enrollment Period

10 months

First QC Date

March 5, 2013

Last Update Submit

January 28, 2014

Conditions

Early Gastric CancerGastric Adenoma

Keywords

Endoscopic submucosal dissectionSedationPropofolMidazolam

Outcome Measures

Primary Outcomes (1)

  • Satisfaction of endoscopists

    Within 10 minutes from the end of the endoscopic submucosal dissection

Study Arms (2)

midazolam/propofol injection

EXPERIMENTAL

Intermittent midazolam/propofol injection controlled by endoscopist

Procedure: Intermittent midazolam/propofol injection controlled by endoscopist

propofol infusion

ACTIVE COMPARATOR

Continuous propofol infusion with opioid administration

Procedure: Continuous propofol infusion with opioid administration

Interventions

Intermittent midazolam/propofol injection controlled by endoscopistPROCEDURE

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.

midazolam/propofol injection
Continuous propofol infusion with opioid administrationPROCEDURE

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.

propofol infusion

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, Seoul, 120-752, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 25803441DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2013

First Posted

March 7, 2013

Study Start

March 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

January 30, 2014

Record last verified: 2014-01

Locations

KR(1)