Remifentanil in Extracorporeal Shock Wave Lithotripsy

Kidney Calculi Clinical Trial

— ESWL  

Official title:

Total Intravenous Anaesthesia Using Remifentanil In Extracorporeal Shock Wave Lithotripsy (ESWL). Comparison of Two Dosages.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01452880
• Other study ID #: francesco cannata
• Status: Completed
• Phase: Phase 4
• First received: October 6, 2011
• Last updated: October 12, 2011
• Start date: January 2010
• Est. completion date: July 2010

Study information

• Verified date: October 2011
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the analgesic efficacy and side effects induced by administration of two different infusion rates of remifentanil, 0,05 mcg/ Kg/ min versus 0,1mcg/ Kg/ min, in order to determine which one is the most appropriate analgesic treatment to face extracorporeal shock wave lithotripsy.

Description:

Remifentanil is an ultra-short-acting oppioid, which is quickly metabolized by unspecific blood and tissue esterases . This feature vouches for a predictable pharmacokinetics and makes this drug suitable for administration in continuous intravenous infusion in order to achieve patient conscious sedation during non-invasive surgical procedures. Remifentanil could be particularly useful in day surgery setting, thanks also to its faster elimination than other oppioids. This property ensure a swift recovery from conscious sedation, reducing the period of time during which patient remains in recovery room and decreasing also the incidence of side effects, like PONV and respiratory depression. Conscious sedation with remifentanil can provide patient comfort and cooperation during surgical procedure, since the verbal contact with the patient is kept up. Extracorporeal shock wave lithotripsy (ESWL) is a non-invasive procedure, contemplated as the first-line treatment for renal and upper ureteral stones, if stone diameter is ranged from 5 to 20 mm . It can grind calculi into fine particles, that are expelled through micturition. Although many studies have been published in regard to continuous intravenous infusion of remifentanil, a small number of them focuses on which is the most appropriate infusion rate for ESWL procedure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• ASA (American Society of anaesthesiology) physical status between the I and class II

• Body mass index (BMI) between 18 and 30.

Exclusion Criteria:

• Patients who were unable to give informed consent or with diagnosis of depression

• Concurrent treatment with antidepressant

• Anxiolytic or with opioids or with history of abuse and dependence from these substances

• Allergy or intolerance to drugs administered in this study

• Severe cognitive deficits or psychiatric disorders

• Liver or renal impairment (aspartate aminotransferase > 40 UI/L alanine aminotransferase > 40 UI/L, creatinine > 2mg/dL)

• Abnormal values of coagulation (International normalized ratio > 1,2), platelet(< 100.000/µL), arrhythmias and / or defect of atrioventricular conduction.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Calculi

Intervention

Drug:
• Remifentanil
Remifentanil is an ultra-short-acting oppioid, which is quickly metabolized by unspecific blood and tissue esterases
• Remifentanil
GROUP A (N = 114): patients assigned to this group received Remifentanil at infusion rate of 0.05 mcg / kg / min I.V. ; GROUP B (N = 114): in this group Remifentanil was administered at infusion rate of 0,1 mcg / kg / min I.V. Remifentanil was administered intravenously throughout ESWL procedure.

Locations

Country	Name	City	State
Italy	Policlinico Umberto I	Rome	Italy/RM

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Medina HJ, Galvin EM, Dirckx M, Banwarie P, Ubben JF, Zijlstra FJ, Klein J, Verbrugge SJ. Remifentanil as a single drug for extracorporeal shock wave lithotripsy: a comparison of infusion doses in terms of analgesic potency and side effects. Anesth Analg. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS score	Before the beginning of ESWL and at the end of the treatment patient were asked to point out the intensity of pain they were feeling on an 11-points visual analog scale (VAS), ranged from 0 "no pain" to 10 "worst pain".	Vas score was monitored up to the end of surgery, for about forty minutes	Yes

External Links

•   European Society of Anaesthesiology