Remifentanil in Extracorporeal Shock Wave Lithotripsy (ESWL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01452880
Recruitment Status : Completed
First Posted : October 17, 2011
Last Update Posted : October 17, 2011
Information provided by (Responsible Party):
Francesco Cannata, University of Roma La Sapienza

October 6, 2011
October 17, 2011
October 17, 2011
January 2010
July 2010   (Final data collection date for primary outcome measure)
VAS score [ Time Frame: Vas score was monitored up to the end of surgery, for about forty minutes ]
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".
Same as current
No Changes Posted
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Remifentanil in Extracorporeal Shock Wave Lithotripsy
Total Intravenous Anaesthesia Using Remifentanil In Extracorporeal Shock Wave Lithotripsy (ESWL). Comparison of Two Dosages.
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.
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.
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Kidney Calculi
  • Drug: Remifentanil
    Remifentanil is an ultra-short-acting oppioid, which is quickly metabolized by unspecific blood and tissue esterases
  • Drug: 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.
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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. 2005 Aug;101(2):365-70, table of contents.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
July 2010
July 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
francesco cannata
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Francesco Cannata, University of Roma La Sapienza
University of Roma La Sapienza
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Principal Investigator: Francesco Cannata, medical doctor policlinico Umberto I Sapienza University of Rome
University of Roma La Sapienza
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP