Remifentanil in Extracorporeal Shock Wave Lithotripsy
Information source: University of Roma La Sapienza
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Kidney Calculi
Intervention: Remifentanil (Drug); Remifentanil (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Roma La Sapienza Official(s) and/or principal investigator(s): Francesco Cannata, medical doctor, Principal Investigator, Affiliation: policlinico Umberto I Sapienza University of Rome
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.
Clinical Details
Official title: Total Intravenous Anaesthesia Using Remifentanil In Extracorporeal Shock Wave Lithotripsy (ESWL). Comparison of Two Dosages.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: VAS score
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
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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.
Locations and Contacts
Policlinico Umberto I, Rome, Italy/RM 00161, Italy
Additional Information
European Society of Anaesthesiology
Starting date: January 2010
Last updated: October 12, 2011
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