- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01998217
Combination of Remifentanil and Flurbiprofen in Sedation and Analgesia for ESWL of Pancreatic Stone
February 2, 2015 updated by: Jia-feng Wang, Changhai Hospital
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Shanghai
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Shanghai, Shanghai, China, 200433
- Department of Anesthesiology, Changhai Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- aged 18-65 years
- ASA I-II
- ESWL indication was met
Exclusion Criteria:
- patients with hypertension
- patients compromised in cardiopulmonary function
- patients undergoing ESWL for the second or more times
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Rem group
Patients in this group receive single infusion of remifentanil with target concentration infusion.
|
Patients in Rem group receive sedation and analgesia with remifentanil, dose of which will be determined by the up-and-down method.
|
Experimental: Flur group
Patients in this group receive both infusion of flurbiprofen and remifentanil
|
Patients in this group receive sedation and analgesia with flurbiprofen and remifentanil, dose of which was determined by the up-and-down method.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Visual analogue score of pain
Time Frame: During ESWL procedure
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During ESWL procedure
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cardiovascular responses including blood pressure and heart rate
Time Frame: During ESWL procedure
|
During ESWL procedure
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Side effects
Time Frame: within 24 hours after ESWL procedure
|
The side effects including postoperative nausea and vomiting, as well as pruritus.
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within 24 hours after ESWL procedure
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
November 19, 2013
First Submitted That Met QC Criteria
November 23, 2013
First Posted (Estimate)
November 28, 2013
Study Record Updates
Last Update Posted (Estimate)
February 4, 2015
Last Update Submitted That Met QC Criteria
February 2, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathological Conditions, Anatomical
- Calculi
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Analgesics, Opioid
- Narcotics
- Remifentanil
- Flurbiprofen
Other Study ID Numbers
- Rem-ESWL-Pancreas
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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