CholecystitisPhase 4NCT02493231
Effect of Intraoperative Nefopam on Acute Pain After Remifentanil Based Anesthesia
A Phase 4 study testing Nefopam, Ketamine and Saline in people with Cholecystitis, run by Hallym University Kangnam Sacred Heart Hospital at 1 site in South Korea.
Trial summary
Many anesthesiologists use the Remifentanil for reducing a surgical pain and stabilizing a vital sign. However, this drug induce postoperative hyperalgesia. Nowadays, many studies report that low-dose Ketamine prevents the opioid-induces hyperalgesia. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Cholecystitis
- What is being tested?
- Nefopam, Ketamine and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2015to Dec 2015
- Phase
- Phase 4
- 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 65 years
- All sexes
- Adult, Older adult
Who may be able to join
- patient who scheduled laparoscopic cholecystectomy under general anesthesia
- American Society of Anesthesiologist(ASA) class I or II
- adult patient (age 20 - 65)
Who cannot join
- patient who has liver disease
- patient who has kidney disease
- patient who has diabetes mellitus(DM) or heart disease
- patient who takes opioid or beta-blocker
- patient who has airway disease
- patient who has allergy with the drug
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Hallym University Kangnam Sacred Heart Hospita
Seoul
Haejin Son, +82-02-829-5527, dandelionc@hallym.or.kr
About this study
Many anesthesiologists use the Remifentanil for reducing a surgical pain and stabilizing a vital sign. However, this drug induce postoperative hyperalgesia. Nowadays, many studies report that low-dose Ketamine prevents the opioid-induces hyperalgesia. Nefopam,which is non-opioid analgesic, has similar mechanism with Ketamine. It will be helpful for postoperative pain control, and reduce the needs of opioid.
- Conditions
- Cholecystitis
- Being tested
- Nefopam, Ketamine, Saline
- Medical subject headings
- Cholecystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NefopamDrug
KetamineDrug
SalineDrug
| Study group | Role | What they receive |
|---|---|---|
| Nefopam | Active comparator | The generic name is 'ACUPAN'. It is infused during operation. A induction dose is 0.3mg/Kg. A maintenance dose is 65 mcg/kg/hr Receives: Drug: Nefopam |
| Ketamine | Active comparator | It is infused during operation. A induction dose is 0.3 mg/Kg. A maintenance dose is 3 mcg/kg/hr Receives: Drug: Ketamine |
| Saline | Placebo comparator | It is infused during operation. A induction volume is 3mL A maintenance dose is 10mL/hr Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
analgesic requirement
Measured: During 1 hour at PACU
duration of analgesic free
Measured: During 1 hour at PACU
Secondary outcomes (2)
analgesic requirement
Measured: During 8 hours after arriving at ward
Pain on the VAS scale
Measured: During 1 hour at PACU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholecystitisStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hallym University Kangnam Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lee Mi Hyeon, Hallym University Kangnam Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02493231
- Sponsor's protocol ID
- 2014-10-133
- Status last verified
- Aug 2015
- First submitted
- 2 Jul 2015
- Last updated
- 2 Sep 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraoperative Nefopam on Acute Pain After Remifentanil Based Anesthesia
- ClinicalTrials.gov ID
- NCT02493231
- Acronym / sponsor ID
- 2014-10-133
- Conditions
- Cholecystitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hallym University Kangnam Sacred Heart HospitalUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2015 (estimated)
- First posted
- 9 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.
Many anesthesiologists use the Remifentanil for reducing a surgical pain and stabilizing a vital sign. However, this drug induce postoperative hyperalgesia. Nowadays, many studies report that low-dose Ketamine prevents the opioid-induces hyperalgesia. Nefopam,which is non-opioid analgesic, has similar mechanism with Ketamine. It will be helpful for postoperative pain control, and reduce the needs of opioid.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nefopam | Active comparator | Drug: NefopamThe generic name is 'ACUPAN'. It is infused during operation. A induction dose is 0.3mg/Kg. A maintenance dose is 65 mcg/kg/hr |
| Ketamine | Active comparator | Drug: KetamineIt is infused during operation. A induction dose is 0.3 mg/Kg. A maintenance dose is 3 mcg/kg/hr |
| Saline | Placebo comparator | Drug: SalineIt is infused during operation. A induction volume is 3mL A maintenance dose is 10mL/hr |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patient who scheduled laparoscopic cholecystectomy under general anesthesia
- American Society of Anesthesiologist(ASA) class I or II
- adult patient (age 20 - 65)
Key exclusion criteria (6 listed)
- patient who has liver disease
- patient who has kidney disease
- patient who has diabetes mellitus(DM) or heart disease
- patient who takes opioid or beta-blocker
- patient who has airway 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 |
|---|---|---|
| Nefopam | Drug | Nefopam |
| Ketamine | Drug | Ketamine |
| Saline | Drug | Saline |
Primary outcome
analgesic requirement
Time frame: During 1 hour at PACU
duration of analgesic free
Time frame: During 1 hour at PACU
2 secondary outcomes
analgesic requirement
Time frame: During 8 hours after arriving at ward
Pain on the VAS scale
Time frame: During 1 hour at PACU
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nefopam, Ketamine and Saline in people with Cholecystitis, run by Hallym University Kangnam Sacred Heart 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 3 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: status not confirmed, as of the sponsor's last update on 2 Sep 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mi hyun Lee (+82-02-829-5230, md1212@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
analgesic requirement (time frame: During 1 hour at PACU). The study lists 2 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 2 Sep 2015.