Pancreatic Stone DiseasePhase 4NCT01998217
Combination of Remifentanil and Flurbiprofen in Sedation and Analgesia for ESWL of Pancreatic Stone
A Phase 4 study testing Remifentanil and Flurbiprofen and remifentanil in people with Pancreatic Stone Disease, run by Changhai Hospital at 1 site in China.
Trial summary
Extracorporeal shock wave lithotripsy (ESWL) of pancreatic stones has been described as an effective approach for stone drainage and pain relief, and general or epidural anesthesia has been reported for such procedure. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pancreatic Stone Disease
- What is being tested?
- Remifentanil and Flurbiprofen and remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Sep 2012to Dec 2013
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18-65 years
- ASA I-II
- ESWL indication was met
Who cannot join
- patients with hypertension
- patients compromised in cardiopulmonary function
- patients undergoing ESWL for the second or more times
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesiology, Changhai Hospital
Shanghai, Shanghai Municipality, 200433
About this study
Extracorporeal shock wave lithotripsy (ESWL) of pancreatic stones has been described as an effective approach for stone drainage and pain relief, and general or epidural anesthesia has been reported for such procedure. Single infusion of remifentanil has been described in ESWL of urinary stones, but it has never been described in ESWL of pancreatic stones. Moreover, single infusion of remifentanil might induce several complications, such as postoperative nausea and vomiting. The investigators attended to investigated whether combination of flurbiprofen with remifentanil reduced remifentanil dose and attenuated the complications.
- Conditions
- Pancreatic Stone Disease
- Being tested
- Remifentanil, Flurbiprofen and remifentanil
- Keywords
- extracorporeal shock wave lithotripsy, remifentanil, flurbiprofen, pancreatic stone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
Patients in Rem group receive sedation and analgesia with remifentanil, dose of which will be determined by the up-and-down method.
Flurbiprofen and remifentanilDrug
Patients in this group receive sedation and analgesia with flurbiprofen and remifentanil, dose of which was determined by the up-and-down method.
| Study group | Role | What they receive |
|---|---|---|
| Rem group | Active comparator | Patients in this group receive single infusion of remifentanil with target concentration infusion. Receives: Drug: Remifentanil |
| Flur group | Experimental | Patients in this group receive both infusion of flurbiprofen and remifentanil Receives: Drug: Flurbiprofen and remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue score of pain
Measured: During ESWL procedure
Secondary outcomes (1)
Cardiovascular responses including blood pressure and heart rate
Measured: During ESWL procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startSep 2012
- Primary completionDec 2013
- Study completionDec 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 Pancreatic Stone DiseaseStudies of the same condition, open and under way.
- More trials run by Changhai 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jia-feng Wang, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01998217
- Sponsor's protocol ID
- Rem-ESWL-Pancreas
- Status last verified
- Feb 2015
- First submitted
- 19 Nov 2013
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yang YG, Hu LH, Chen H, Li B, Fan XH, Li JB, Wang JF, Deng XM. Target-controlled infusion of remifentanil with or without flurbiprofen axetil in sedation for extracorporeal shock wave lithotripsy of pancreatic stones: a prospective, open-label, randomized controlled trial. BMC Anesthesiol. 2015 Nov 7;15:161. doi: 10.1186/s12871-015-0141-6.
PubMed 26547293
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Remifentanil and Flurbiprofen in Sedation and Analgesia for ESWL of Pancreatic Stone
- ClinicalTrials.gov ID
- NCT01998217
- Acronym / sponsor ID
- Rem-ESWL-Pancreas
- Conditions
- Pancreatic Stone Disease
- Keywords
- extracorporeal shock wave lithotripsy, remifentanil, flurbiprofen, pancreatic stone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 28 Nov 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.
Extracorporeal shock wave lithotripsy (ESWL) of pancreatic stones has been described as an effective approach for stone drainage and pain relief, and general or epidural anesthesia has been reported for such procedure. Single infusion of remifentanil has been described in ESWL of urinary stones, but it has never been described in ESWL of pancreatic stones. Moreover, single infusion of remifentanil might induce several complications, such as postoperative nausea and vomiting. The investigators attended to investigated whether combination of flurbiprofen with remifentanil reduced remifentanil dose and attenuated the complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rem group | Active comparator | Drug: RemifentanilPatients in this group receive single infusion of remifentanil with target concentration infusion. |
| Flur group | Experimental | Drug: Flurbiprofen and remifentanilPatients in this group receive both infusion of flurbiprofen and remifentanil |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged 18-65 years
- ASA I-II
- ESWL indication was met
Key exclusion criteria (3 listed)
- patients with hypertension
- patients compromised in cardiopulmonary function
- patients undergoing ESWL for the second or more times
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 |
|---|---|---|
| RemifentanilPatients in Rem group receive sedation and analgesia with remifentanil, dose of which will be determined by the up-and-down method. | Drug | Rem group |
| Flurbiprofen and remifentanilPatients in this group receive sedation and analgesia with flurbiprofen and remifentanil, dose of which was determined by the up-and-down method. | Drug | Flur group |
Primary outcome
Visual analogue score of pain
Time frame: During ESWL procedure
1 secondary outcome
Cardiovascular responses including blood pressure and heart rate
Time frame: During ESWL procedure
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 4 Feb 2015.
- Derived from this study: PubMed 26547293Yang YG, Hu LH, Chen H, Li B, Fan XH, Li JB, Wang JF, Deng XM. Target-controlled infusion of remifentanil with or without flurbiprofen axetil in sedation for extracorporeal shock wave lithotripsy of pancreatic stones: a prospective, open-label, randomized controlled trial. BMC Anesthesiol. 2015 Nov 7;15:161. doi: 10.1186/s12871-015-0141-6.
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 Phase 4 study testing Remifentanil and Flurbiprofen and remifentanil in people with Pancreatic Stone Disease, run by Changhai Hospital at 1 site in China.
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 3 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 4 Feb 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 China. 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.
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?
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?
Visual analogue score of pain (time frame: During ESWL procedure). 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 NCT01998217, 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 4 Feb 2015.