Early Gastric CancerNCT02504164
Effect of Midazolam Premedication on the Satisfaction Levels of Patients After Endoscopic Submucosal Dissection
A study testing midazolam 0.02mg/kg and No premedication in people with Early Gastric Cancer and Gastric Adenoma, run by Yonsei University at 1 site in South Korea.
Trial summary
Endoscopic submucosal dissection is commonly performed under light to moderate sedation, and minimizing patient movement is of key importance for successful outcome. Propofol has widely replaced benzodiazepines as sedative drug of choice, and has been reported to enhance the quality of procedure in our past study. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Early Gastric Cancer, Gastric Adenoma
- What is being tested?
- midazolam 0.02mg/kg and No premedication
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2014to Dec 2015
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients over the age of 19 diagnosed with early gastric cancer or gastric adenoma that are scheduled for endoscopic submucosal dissection
- American society of anesthesiologist physical status 1~3
Who cannot join
- Patient refusal
- Patients that received sedatives within 24 hours prior to endoscopic submucosal dissection
- History of gastrectomy or previous endoscopic submucosal dissection at same site
- Allergies to propofol or its ingredients, soybeans or peanuts
- Pregnant or breastfeeding patients
- Patients with severe debilitating underlying medical conditions
- Patients with altered mental status
- Illiterate patients or foreigners
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Seoul, Seoul, 120-752
About this study
Endoscopic submucosal dissection is commonly performed under light to moderate sedation, and minimizing patient movement is of key importance for successful outcome. Propofol has widely replaced benzodiazepines as sedative drug of choice, and has been reported to enhance the quality of procedure in our past study. However, despite higher satisfaction scores of the endoscopists and faster post-procedural recovery, patient satisfaction scores were found to be higher in patients that received midazolam and meperidine instead of propofol and remifentanil. This seems to be due to the anterograde amnestic effects of midazolam rather than the quality of sedation itself. Investigator hypothesized that by premedicating the patient with low lose midazolam before receiving sedation for ESD with propofol and fentanyl, patient satisfaction would be enhanced without affecting endoscopic performance.
- Conditions
- Early Gastric Cancer, Gastric Adenoma
- Being tested
- midazolam 0.02mg/kg, No premedication
- Keywords
- midazolam, satisfaction, endoscopic submucosal dissection
- Medical subject headings
- Stomach Neoplasms, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
midazolam 0.02mg/kgDrug
Also called Premedication of midazolam 0.02mg/kg before sedation for endoscopic submucosal dissection
No premedicationDrug
No premedication before sedation for endoscopic submucosal dissection
| Study group | Role | What they receive |
|---|---|---|
| No premedication | Experimental | No premedication before sedation Receives: Drug: No premedication |
| Midazolam | Active comparator | Premedication with midazolam before sedation Receives: Drug: midazolam 0.02mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall patient satisfaction scores on a scale from 0 to 10
Measured: 24 hours after ESD
Willingness to receive same method of sedation for ESD in the future as yes or no
Measured: 24 hours after ESD
Post-procedural pain on a VAS scale of 0 to 10
Measured: at 1 hour and 24 hours after ESD
Any recall of the ESD procedure on a scale from 0 to 2 (0; no recall, 1; partial recall, 2; can recall most of procedure)
Measured: 24 hours after ESD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2015 (estimated)
- Study startSep 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Gastric CancerStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 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
- NCT02504164
- Sponsor's protocol ID
- 4-2014-0310
- Status last verified
- Mar 2016
- First submitted
- 14 Jul 2015
- Last updated
- 7 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Midazolam Premedication on the Satisfaction Levels of Patients After Endoscopic Submucosal Dissection
- ClinicalTrials.gov ID
- NCT02504164
- Acronym / sponsor ID
- 4-2014-0310
- Conditions
- Early Gastric Cancer, Gastric Adenoma
- Keywords
- midazolam, satisfaction, endoscopic submucosal dissection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 21 Jul 2015 (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.
Endoscopic submucosal dissection is commonly performed under light to moderate sedation, and minimizing patient movement is of key importance for successful outcome. Propofol has widely replaced benzodiazepines as sedative drug of choice, and has been reported to enhance the quality of procedure in our past study. However, despite higher satisfaction scores of the endoscopists and faster post-procedural recovery, patient satisfaction scores were found to be higher in patients that received midazolam and meperidine instead of propofol and remifentanil. This seems to be due to the anterograde amnestic effects of midazolam rather than the quality of sedation itself. Investigator hypothesized that by premedicating the patient with low lose midazolam before receiving sedation for ESD with propofol and fentanyl, patient satisfaction would be enhanced without affecting endoscopic performance.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No premedication | Experimental | Drug: No premedicationNo premedication before sedation |
| Midazolam | Active comparator | Drug: midazolam 0.02mg/kgPremedication with midazolam before sedation |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients over the age of 19 diagnosed with early gastric cancer or gastric adenoma that are scheduled for endoscopic submucosal dissection
- American society of anesthesiologist physical status 1~3
Key exclusion criteria (8 listed)
- Patient refusal
- Patients that received sedatives within 24 hours prior to endoscopic submucosal dissection
- History of gastrectomy or previous endoscopic submucosal dissection at same site
- Allergies to propofol or its ingredients, soybeans or peanuts
- Pregnant or breastfeeding patients
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 |
|---|---|---|
| midazolam 0.02mg/kgAlso: Premedication of midazolam 0.02mg/kg before sedation for endoscopic submucosal dissection | Drug | Midazolam |
| No premedicationNo premedication before sedation for endoscopic submucosal dissection | Drug | No premedication |
Primary outcome
Overall patient satisfaction scores on a scale from 0 to 10
Time frame: 24 hours after ESD
Willingness to receive same method of sedation for ESD in the future as yes or no
Time frame: 24 hours after ESD
Post-procedural pain on a VAS scale of 0 to 10
Time frame: at 1 hour and 24 hours after ESD
Any recall of the ESD procedure on a scale from 0 to 2 (0; no recall, 1; partial recall, 2; can recall most of procedure)
Time frame: 24 hours after ESD
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 7 Mar 2016.
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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 midazolam 0.02mg/kg and No premedication in people with Early Gastric Cancer and Gastric Adenoma, 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 2 inclusion and 8 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 7 Mar 2016. 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?
Overall patient satisfaction scores on a scale from 0 to 10 (time frame: 24 hours after ESD). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Mar 2016.