Stomach NeoplasmsNCT02561494
Postoperative Analgesic Effect of Nefopam
A study testing Nefopam and Saline in people with Stomach Neoplasms, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
Nefopam will be administered to the patients undergoing laparoscopic gastrectomy under the total intravenous anesthesia (TIVA). The investigators will evaluate whether the nefopam can decrease the total amount of remifentanil administered during the operation, which will reduce the acute opioid tolerance and following… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Stomach Neoplasms
- What is being tested?
- Nefopam and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2015to Aug 2016
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Early or advanced gastric cancer
Who cannot join
- Refusal
- Use of preoperative analgesic drugs
- Pregnancy
- Recurred gastric cancer
- Seizure
- Cardiac disease
Show all 10Show fewer
- Monoamine oxidase inhibitor
- Urologic disease
- Previous intrabdominal surgery
- Body mass index > 30 or < 16
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 443-607
About this study
Nefopam will be administered to the patients undergoing laparoscopic gastrectomy under the total intravenous anesthesia (TIVA).
The investigators will evaluate whether the nefopam can decrease the total amount of remifentanil administered during the operation, which will reduce the acute opioid tolerance and following consumption of fentanyl during postoperative period.
- Conditions
- Stomach Neoplasms
- Being tested
- Nefopam, 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.
NefopamDrug
SalineDrug
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Intravenous normal saline 2 ml is given slowly as a placebo before the anesthesia induction and after finishing anesthesia. Receives: Drug: Saline |
| Nefopam | Experimental | Intravenous nefopam 20 mg is given slowly before the anesthesia induction and after finishing anesthesia. Receives: Drug: Nefopam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the administered fentanyl dose from postoperative 6 h to postoperative 5 day
Measured: postoperative 6 h, postoperative 1 day, postoperative 2 day, postoperative 3 day, postoperative 5 day
Secondary outcomes (1)
Change of the pain score from postoperative 6 h to postoperative 5 day
Measured: postoperative 6 h, postoperative 1 day, postoperative 2 day, postoperative 3 day, postoperative 5 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2015 (estimated)
- Study startJun 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyo-Seok Na, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02561494
- Sponsor's protocol ID
- Nefo_stomach op
- Status last verified
- Oct 2016
- First submitted
- 2 Aug 2015
- Last updated
- 28 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Analgesic Effect of Nefopam
- ClinicalTrials.gov ID
- NCT02561494
- Acronym / sponsor ID
- Nefo_stomach op
- Conditions
- Stomach Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 28 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.
Nefopam will be administered to the patients undergoing laparoscopic gastrectomy under the total intravenous anesthesia (TIVA).
The investigators will evaluate whether the nefopam can decrease the total amount of remifentanil administered during the operation, which will reduce the acute opioid tolerance and following consumption of fentanyl during postoperative period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: SalineIntravenous normal saline 2 ml is given slowly as a placebo before the anesthesia induction and after finishing anesthesia. |
| Nefopam | Experimental | Drug: NefopamIntravenous nefopam 20 mg is given slowly before the anesthesia induction and after finishing anesthesia. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Early or advanced gastric cancer
Key exclusion criteria (10 listed)
- Refusal
- Use of preoperative analgesic drugs
- Pregnancy
- Recurred gastric cancer
- Seizure
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 |
|---|---|---|
| Nefopam | Drug | Nefopam |
| Saline | Drug | Control |
Primary outcome
Change of the administered fentanyl dose from postoperative 6 h to postoperative 5 day
Time frame: postoperative 6 h, postoperative 1 day, postoperative 2 day, postoperative 3 day, postoperative 5 day
1 secondary outcome
Change of the pain score from postoperative 6 h to postoperative 5 day
Time frame: postoperative 6 h, postoperative 1 day, postoperative 2 day, postoperative 3 day, postoperative 5 day
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 28 Oct 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 Nefopam and Saline in people with Stomach Neoplasms, run by Seoul National University Bundang 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 10 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 28 Oct 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. 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?
Change of the administered fentanyl dose from postoperative 6 h to postoperative 5 day (time frame: postoperative 6 h, postoperative 1 day, postoperative 2 day, postoperative 3 day, postoperative 5 day). 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 28 Oct 2016.