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

Phase 4

Completed

• Conditions: Pancreatic Stone Disease
• Interventions: Drug: Flurbiprofen and remifentanil; Drug: Remifentanil

• Registration Number: NCT01998217
• Lead Sponsor: Changhai Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-11-19
• Study First Submitted QC: 2013-11-23
• Study First Posted: 2013-11-28
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-02
• Last Update Posted: 2015-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flur group	Flurbiprofen and remifentanil	Patients in this group receive both infusion of flurbiprofen and remifentanil
Rem group	Remifentanil	Patients in this group receive single infusion of remifentanil with target concentration infusion.

Primary Outcome Measures

Name	Time	Method
Visual analogue score of pain	During ESWL procedure

Secondary Outcome Measures

Name	Time	Method
Cardiovascular responses including blood pressure and heart rate	During ESWL procedure

Trial Locations

Locations (1)

Department of Anesthesiology, Changhai Hospital; 🇨🇳 Shanghai, Shanghai, China