Clinical trial NCT01452880: Remifentanil in Extracorporeal Shock Wave Lithotripsy
Official title: Total Intravenous Anaesthesia Using Remifentanil In Extracorporeal Shock Wave Lithotripsy (ESWL). Comparison of Two Dosages.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Calculi
Keywords: Remifentanil
Lithotripsy
Conscious Sedation
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2011-10-17
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: VAS score
timeFrame: Vas score was monitored up to the end of surgery, for about forty minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Policlinico Umberto I
state: Italy/RM
Study officials:
affiliation: policlinico Umberto I Sapienza University of Rome
name: Francesco Cannata, medical doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Medina HJ, Galvin EM, Dirckx M, Banwarie P, Ubben JFH, Zijlstra FJ, Klein J, Verbrugge SJC. 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. 2005 Aug;101(2):365-370. doi: 10.1213/01.ANE.0000159379.54705.84.