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Remifentanil in Extracorporeal Shock Wave Lithotripsy (ESWL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Francesco Cannata, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01452880
First received: October 6, 2011
Last updated: October 12, 2011
Last verified: October 2011
History of Changes
  Purpose

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 Intervention Phase
Kidney Calculi
 Drug: Remifentanil
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Total Intravenous Anaesthesia Using Remifentanil In Extracorporeal Shock Wave Lithotripsy (ESWL). Comparison of Two Dosages.

Resource links provided by NLM:

MedlinePlus related topics: Shock
U.S. FDA Resources

Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • VAS score [ Time Frame: Vas score was monitored up to the end of surgery, for about forty minutes ] [ Designated as safety issue: Yes ]
    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".


Enrollment: 228
Study Start Date: January 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
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.
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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01452880

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

Additional Information:
European Society of Anaesthesiology  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Francesco Cannata, medical doctor, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT01452880     History of Changes
Other Study ID Numbers: francesco cannata
Study First Received: October 6, 2011
Last Updated: October 12, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by University of Roma La Sapienza:
Remifentanil
Lithotripsy
Conscious Sedation

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

ClinicalTrials.gov processed this record on May 23, 2013