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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01998217

Enrollment

Registered

2013-11-28

Start date

2012-09-30

Completion date

2013-12-31

Last updated

2015-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Stone Disease

Keywords

extracorporeal shock wave lithotripsy, remifentanil, flurbiprofen, pancreatic stone

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.

Interventions

DRUGRemifentanil

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

DRUGFlurbiprofen 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Visual analogue score of pain	During ESWL procedure

Secondary

Measure	Time frame
Cardiovascular responses including blood pressure and heart rate	During ESWL procedure

Other

Measure	Time frame	Description
Side effects	within 24 hours after ESWL procedure	The side effects including postoperative nausea and vomiting, as well as pruritus.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026