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

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.

Condition or disease Intervention/treatment Phase
Kidney Calculi Drug: Remifentanil Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 228 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Total Intravenous Anaesthesia Using Remifentanil In Extracorporeal Shock Wave Lithotripsy (ESWL). Comparison of Two Dosages.
Study Start Date : January 2010
Primary Completion Date : July 2010
Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock
U.S. FDA Resources

Intervention Details:
    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.

Primary Outcome Measures :
  1. 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".

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01452880

Policlinico Umberto I
Rome, Italy/RM, Italy, 00161
Sponsors and Collaborators
University of Roma La Sapienza
Principal Investigator: Francesco Cannata, medical doctor policlinico Umberto I Sapienza University of Rome

Additional Information:
Publications of Results:
Responsible Party: Francesco Cannata, medical doctor, University of Roma La Sapienza Identifier: NCT01452880     History of Changes
Other Study ID Numbers: francesco cannata
First Posted: October 17, 2011    Key Record Dates
Last Update Posted: October 17, 2011
Last Verified: October 2011

Keywords provided by Francesco Cannata, University of Roma La Sapienza:
Conscious Sedation

Additional relevant MeSH terms:
Kidney Calculi
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urinary Calculi
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General