A Comparison of Efficacy and Safety During Endoscopic Submucosal Dissection Between Dexmedetomidine-remifentanil and Propofol-remifentanil

January 7, 2015 updated by: Yonsei University
Adequate, safe sedation is essential for Endoscopic submucosal dissection. Dexmedetomidine is a potent and selective a2-adrenoceptor agonist used for sedative and analgesic effects, but it is limited to use alone. The investigators designed this study to compare the effect and safety of two sedatives, dexmedetomidine and propofol in Endoscopic Submucosal Dissection (ESD), when sufficient analgesia-remifentanil is administered all throughout the procedure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

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

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Anesthesiology & Pain Medicine, Yonsei university college of medicine

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 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥20
  • American Society of Anaesthesiologists(ASA) physical status classification I~III
  • Early gastric cancer patients who were scheduled for Endoscopic submucosal dissection

Exclusion Criteria:

  • Age < 20
  • American Society of Anaesthesiologists(ASA) physical status classification IV
  • those with end-organ diseases (i.e. heart failure, respiratory failure, hepatic failure, renal failure)
  • known drug allergies or history of drug abuse
  • psychological disease

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: DR group
In Group DR, a bolus dose of 0.5mcg/kg dexmedetomidine was injected intravenously 5 minutes before the start of the procedure (Precedex®, Abbott, Istanbul, Turkey). And a continuous infusion dose of 0.3-0.7mcg/hr/kg was started.
Drug: Dexmedetomidine - remifentanil group
ACTIVE_COMPARATOR: PR group
In Group PR, a bolus injection of 1 mg/kg of propofol was followed by a continuous infusion at a rate of 3-5mg/hr/kg(Pofol®, Dongkook Pharm. Co. Ltd., Seoul, Korea) using an infusion pump (Syringe Pump TE-331, Terumo Japan).
Drug: Propofol - remifentanil group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A comparison of safety during endoscopic submucosal dissection between dexmedetomidine-remifentanil and propofol-remifentanil
Time Frame: right after the drugs had administered

Safety : whether the complications as follows occur or not

  1. systolic blood pressure under 90mmHg or 20% out of range of the baseline SBP
  2. heart rate under 50bpm
  3. oxygen saturation under 90%, respiratory rate under 7 per minute
right after the drugs had administered

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A comparison of efficacy during endoscopic submucosal dissection between dexmedetomidine-remifentanil and propofol-remifentanil
Time Frame: right after the drugs had administered

Efficacy :

  1. whether a bolus injection of 10 mg of propofol was administered or not
  2. evaluating the depth of sedation using MOAA/S scale all through the procedure
  3. whether the en bloc resection, complete resection were done or not under the sedation
right after the drugs had administered

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
A comparison of patient's satisfaction during endoscopic submucosal dissection between dexmedetomidine-remifentanil and propofol-remifentanil
Time Frame: within 24hrs after procedure
Patients' satisfaction : investigate in four steps questionaire (very good, good, bearable and unbearable) when the patients' were discharged from PACU
within 24hrs after procedure
A comparison of gastric motility, easiness for procedure, operator's satisfaction during endoscopic submucosal dissection between dexmedetomidine-remifentanil and propofol-remifentanil
Time Frame: right after the drugs had administered
Subjects' motility grading during procedure, easiness of procedure, operator's satisfaction : investigate in four steps questionaires by the operator after the procedure
right after the drugs had administered

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

October 1, 2012

Primary Completion (ACTUAL)

January 1, 2013

Study Completion (ACTUAL)

March 1, 2013

Study Registration Dates

First Submitted

July 23, 2013

First Submitted That Met QC Criteria

August 6, 2013

First Posted (ESTIMATE)

August 9, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 9, 2015

Last Update Submitted That Met QC Criteria

January 7, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2012-0621

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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