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

• Sponsor: Changhai Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01998217
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 15
• Patients Per Site Per Month: 4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Stone Disease	Drug: Remifentanil; Drug: Flurbiprofen and remifentanil	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Sep 1, 2012
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Rem group Patients in this group receive single infusion of remifentanil with target concentration infusion.	Drug: Remifentanil; Patients in Rem group receive sedation and analgesia with remifentanil, dose of which will be determined by the up-and-down method.
Experimental: Flur group Patients in this group receive both infusion of flurbiprofen and remifentanil	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.

Outcome Measures

Primary Outcome Measures

1. Visual analogue score of pain [During ESWL procedure]

Secondary Outcome Measures

1. Cardiovascular responses including blood pressure and heart rate [During ESWL procedure]

Other Outcome Measures

1. Side effects [within 24 hours after ESWL procedure]

   The side effects including postoperative nausea and vomiting, as well as pruritus.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology, Changhai Hospital	Shanghai	Shanghai	China	200433

Sponsors and Collaborators

• Changhai Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jia-feng Wang, M.D., Changhai Hospital
• ClinicalTrials.gov Identifier: NCT01998217
• Other Study ID Numbers: Rem-ESWL-Pancreas
• First Posted: Nov 28, 2013
• Last Update Posted: Feb 4, 2015
• Last Verified: Feb 1, 2015

• Keywords provided by Jia-feng Wang, M.D., Changhai Hospital: extracorporeal shock wave lithotripsy; remifentanil; flurbiprofen; pancreatic stone
• Additional relevant MeSH terms: Calculi; Flurbiprofen; Remifentanil

Study Results

No Results Posted as of Feb 4, 2015