Back to resultsCombination of Remifentanil and Flurbiprofen in Sedation and Analgesia for ESWL of Pancreatic Stone
Primary Purpose
Pancreatic Stone Disease
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Remifentanil
Flurbiprofen and remifentanil
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Stone Disease focused on measuring extracorporeal shock wave lithotripsy, remifentanil, flurbiprofen, pancreatic stone
Eligibility Criteria
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
Sites / Locations
- Department of Anesthesiology, Changhai Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Rem group
Flur group
Arm Description
Patients in this group receive single infusion of remifentanil with target concentration infusion.
Patients in this group receive both infusion of flurbiprofen and remifentanil
Outcomes
Primary Outcome Measures
Visual analogue score of pain
Secondary Outcome Measures
Cardiovascular responses including blood pressure and heart rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01998217
Brief Title
Combination of Remifentanil and Flurbiprofen in Sedation and Analgesia for ESWL of Pancreatic Stone
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhai Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Stone Disease
Keywords
extracorporeal shock wave lithotripsy, remifentanil, flurbiprofen, pancreatic stone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rem group
Arm Type
Active Comparator
Arm Description
Patients in this group receive single infusion of remifentanil with target concentration infusion.
Arm Title
Flur group
Arm Type
Experimental
Arm Description
Patients in this group receive both infusion of flurbiprofen and remifentanil
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Intervention Description
Patients in Rem group receive sedation and analgesia with remifentanil, dose of which will be determined by the up-and-down method.
Intervention Type
Drug
Intervention Name(s)
Flurbiprofen and remifentanil
Intervention Description
Patients in this group receive sedation and analgesia with flurbiprofen and remifentanil, dose of which was determined by the up-and-down method.
Primary Outcome Measure Information:
Title
Visual analogue score of pain
Time Frame
During ESWL procedure
Secondary Outcome Measure Information:
Title
Cardiovascular responses including blood pressure and heart rate
Time Frame
During ESWL procedure
Other Pre-specified Outcome Measures:
Title
Side effects
Description
The side effects including postoperative nausea and vomiting, as well as pruritus.
Time Frame
within 24 hours after ESWL procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Anesthesiology, Changhai Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
26547293
Citation
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.
Results Reference
derived
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Combination of Remifentanil and Flurbiprofen in Sedation and Analgesia for ESWL of Pancreatic Stone
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