Gastric NeoplasmNCT02543411
Use of Lidocaine in Endoscopic Submucosal Dissection
A study testing Lidocaine 1% and Normal saline in people with Gastric Neoplasm, run by Severance Hospital at 1 site in South Korea.
Trial summary
The primary purpose of this study is to investigate the effects of lidocaine on the total administered dose of fentanyl during sedation for endoscopic mucosal resection. The secondary purpose of this study is to investigate the effects of lidocaine on pain score related with endoscopic mucosal resection at time of 30… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Gastric Neoplasm
- What is being tested?
- Lidocaine 1% and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2015to Nov 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Endoscopic submucosal dissection for the treatments of early gastric neoplasm
Who cannot join
- Allergy to lidocaine
- Chronic pain
- Chronic abuse of opioid or NSAID
- Atrioventricular conductance block
- Liver dysfunction
- Renal dysfunction
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Severance Hospital, Yonsei University College of Medicine
Seoul
About this study
Official title: Effect of Intravenous Lidocaine During Endoscopic Submucosal Dissection for Gastric Neoplasm
The primary purpose of this study is to investigate the effects of lidocaine on the total administered dose of fentanyl during sedation for endoscopic mucosal resection.
The secondary purpose of this study is to investigate the effects of lidocaine on pain score related with endoscopic mucosal resection at time of 30 min, 6 hr, and 24 hr after procedure.
- Conditions
- Gastric Neoplasm
- Being tested
- Lidocaine 1%, Normal saline
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine 1%Drug
Intravenous administration as bolus of lidocaine 1.5 mg/kg before sedation and infusion of lidocaine 2 mg/kg/hr during sedation.
Sedation with fentanyl and propofol
Normal salineDrug
Intravenous administration as bolus of normal saline 0.15 mL/kg before sedation and infusion of normal saline 0.2 mL/kg/hr during sedation.
Sedation with fentanyl and propofol
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine group | Experimental | Administration of lidocaine 1% Receives: Drug: Lidocaine 1% |
| Control group | Placebo comparator | Administration of normal saline Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fentanyl consumption during sedation
Measured: During sedation, an expected average of 40 minutes
Secondary outcomes (2)
Pain intensity measured by numerical rating scale
0 = no pain at all and 10 = worst pain imaginable (11-point numerical rating scale)
Measured: 30 min, 6 hr, and 24 hr after procedure
Incidence of nausea and vomiting
Nausea requiring antiemetics and retching and/or vomiting
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric NeoplasmStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, So Yeon Kim, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02543411
- Sponsor's protocol ID
- 4-2014-0933
- Status last verified
- Dec 2015
- First submitted
- 2 Sep 2015
- Last updated
- 15 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Lidocaine During Endoscopic Submucosal Dissection for Gastric Neoplasm
- ClinicalTrials.gov ID
- NCT02543411
- Acronym / sponsor ID
- 4-2014-0933
- Conditions
- Gastric Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Severance HospitalUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Nov 2015 (actual)
- First posted
- 7 Sep 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.
The primary purpose of this study is to investigate the effects of lidocaine on the total administered dose of fentanyl during sedation for endoscopic mucosal resection.
The secondary purpose of this study is to investigate the effects of lidocaine on pain score related with endoscopic mucosal resection at time of 30 min, 6 hr, and 24 hr after procedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine group | Experimental | Drug: Lidocaine 1%Administration of lidocaine 1% |
| Control group | Placebo comparator | Drug: Normal salineAdministration of normal saline |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Endoscopic submucosal dissection for the treatments of early gastric neoplasm
Key exclusion criteria (6 listed)
- Allergy to lidocaine
- Chronic pain
- Chronic abuse of opioid or NSAID
- Atrioventricular conductance block
- Liver dysfunction
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 |
|---|---|---|
| Lidocaine 1%Intravenous administration as bolus of lidocaine 1.5 mg/kg before sedation and infusion of lidocaine 2 mg/kg/hr during sedation. Sedation with fentanyl and propofol | Drug | Lidocaine group |
| Normal salineIntravenous administration as bolus of normal saline 0.15 mL/kg before sedation and infusion of normal saline 0.2 mL/kg/hr during sedation. Sedation with fentanyl and propofol | Drug | Control group |
Primary outcome
Fentanyl consumption during sedation
Time frame: During sedation, an expected average of 40 minutes
2 secondary outcomes
Pain intensity measured by numerical rating scale
Time frame: 30 min, 6 hr, and 24 hr after procedure
Incidence of nausea and vomiting
Time frame: Up to 24 hours
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 15 Dec 2015.
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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 Lidocaine 1% and Normal saline in people with Gastric Neoplasm, run by Severance Hospital 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 1 inclusion and 6 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 15 Dec 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. Some participants in this study may receive a placebo. 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?
Fentanyl consumption during sedation (time frame: During sedation, an expected average of 40 minutes). 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 15 Dec 2015.