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Clinical Trials/NCT01998217
NCT01998217CompletedPhase 4

Combination of Remifentanil and Flurbiprofen in Sedation and Analgesia for ESWL of Pancreatic Stone

Changhai Hospital1 site in 1 country60 target enrollmentStarted: September 2012Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
Visual analogue score of pain

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • aged 18-65 years
  • ESWL indication was met

Exclusion Criteria

  • patients with hypertension
  • patients compromised in cardiopulmonary function
  • patients undergoing ESWL for the second or more times

Arms & Interventions

Flur group

Experimental

Patients in this group receive both infusion of flurbiprofen and remifentanil

Intervention: Flurbiprofen and remifentanil (Drug)

Rem group

Active Comparator

Patients in this group receive single infusion of remifentanil with target concentration infusion.

Intervention: Remifentanil (Drug)

Outcomes

Primary Outcomes

Visual analogue score of pain

Time Frame: During ESWL procedure

Secondary Outcomes

  • Cardiovascular responses including blood pressure and heart rate(During ESWL procedure)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jia-feng Wang

M.D.

Changhai Hospital

Study Sites (1)

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