Early Gastric Cancer Patients Who Were Scheduled for Endoscopic Submucosal DissectionNCT01920113
A Comparison of Efficacy and Safety During Endoscopic Submucosal Dissection Between Dexmedetomidine-remifentanil and Propofol-remifentanil
A study testing Dexmedetomidine - remifentanil group and Propofol - remifentanil group in people with Early Gastric Cancer Patients Who Were Scheduled for Endoscopic Submucosal Dissection, run by Yonsei University at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Early Gastric Cancer Patients Who Were Scheduled for Endoscopic Submucosal Dissection
- What is being tested?
- Dexmedetomidine - remifentanil group and Propofol - remifentanil group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2012to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥20
- American Society of Anaesthesiologists(ASA) physical status classification I~III
- Early gastric cancer patients who were scheduled for Endoscopic submucosal dissection
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Anesthesiology & Pain Medicine, Yonsei university college of medicine
Seoul, 120-752
About this study
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.
- Being tested
- Dexmedetomidine - remifentanil group, Propofol - remifentanil group
- Keywords
- Endoscopic submucosal dissection, propofol, remifentanil, dexmedetomidine, efficacy, safeness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine - remifentanil groupDrug
Propofol - remifentanil groupDrug
| Study group | Role | What they receive |
|---|---|---|
| DR group | Experimental | 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. Receives: Drug: Dexmedetomidine - remifentanil group |
| PR group | Active comparator | 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). Receives: Drug: Propofol - remifentanil group |
What is being measured
The primary outcome is the main question the study is designed to answer.
A comparison of safety during endoscopic submucosal dissection between dexmedetomidine-remifentanil and propofol-remifentanil
Safety : whether the complications as follows occur or not
- systolic blood pressure under 90mmHg or 20% out of range of the baseline SBP
- heart rate under 50bpm
- oxygen saturation under 90%, respiratory rate under 7 per minute
Measured: right after the drugs had administered
Secondary outcomes (1)
A comparison of efficacy during endoscopic submucosal dissection between dexmedetomidine-remifentanil and propofol-remifentanil
Efficacy :
- whether a bolus injection of 10 mg of propofol was administered or not
- evaluating the depth of sedation using MOAA/S scale all through the procedure
- whether the en bloc resection, complete resection were done or not under the sedation
Measured: right after the drugs had administered
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2013 (estimated)
- Study startOct 2012
- Primary completionJan 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Early Gastric Cancer Patients Who Were Scheduled for Endoscopic Submucosal DissectionStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01920113
- Sponsor's protocol ID
- 4-2012-0621
- Status last verified
- Jan 2015
- First submitted
- 23 Jul 2013
- Last updated
- 9 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim N, Yoo YC, Lee SK, Kim H, Ju HM, Min KT. Comparison of the efficacy and safety of sedation between dexmedetomidine-remifentanil and propofol-remifentanil during endoscopic submucosal dissection. World J Gastroenterol. 2015 Mar 28;21(12):3671-8. doi: 10.3748/wjg.v21.i12.3671.
PubMed 25834336
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Efficacy and Safety During Endoscopic Submucosal Dissection Between Dexmedetomidine-remifentanil and Propofol-remifentanil
- ClinicalTrials.gov ID
- NCT01920113
- Acronym / sponsor ID
- 4-2012-0621
- Keywords
- Endoscopic submucosal dissection, propofol, remifentanil, dexmedetomidine, efficacy, safeness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 9 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DR group | Experimental | Drug: Dexmedetomidine - remifentanil groupIn 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. |
| PR group | Active comparator | Drug: Propofol - remifentanil groupIn 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). |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥20
- American Society of Anaesthesiologists(ASA) physical status classification I~III
- Early gastric cancer patients who were scheduled for Endoscopic submucosal dissection
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidine - remifentanil group | Drug | DR group |
| Propofol - remifentanil group | Drug | PR group |
Primary outcome
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
1 secondary outcome
A comparison of efficacy during endoscopic submucosal dissection between dexmedetomidine-remifentanil and propofol-remifentanil
Time frame: right after the drugs had administered
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2015.
- Derived from this study: PubMed 25834336Kim N, Yoo YC, Lee SK, Kim H, Ju HM, Min KT. Comparison of the efficacy and safety of sedation between dexmedetomidine-remifentanil and propofol-remifentanil during endoscopic submucosal dissection. World J Gastroenterol. 2015 Mar 28;21(12):3671-8. doi: 10.3748/wjg.v21.i12.3671.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine - remifentanil group and Propofol - remifentanil group in people with Early Gastric Cancer Patients Who Were Scheduled for Endoscopic Submucosal Dissection, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A comparison of safety during endoscopic submucosal dissection between dexmedetomidine-remifentanil and propofol-remifentanil (time frame: right after the drugs had administered). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01920113, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2015.