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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2013

Interventions

  • Drug: Remifentanil
    • Patients in Rem group receive sedation and analgesia with remifentanil, dose of which will be determined by the up-and-down method.
  • Drug: 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.

Arms, Groups and Cohorts

  • Active Comparator: Rem group
    • Patients in this group receive single infusion of remifentanil with target concentration infusion.
  • Experimental: Flur group
    • Patients in this group receive both infusion of flurbiprofen and remifentanil

Clinical Trial Outcome Measures

Primary Measures

  • Visual analogue score of pain
    • Time Frame: During ESWL procedure

Secondary Measures

  • Cardiovascular responses including blood pressure and heart rate
    • Time Frame: During ESWL procedure

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Changhai Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jia-feng Wang, M.D. – Changhai Hospital

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