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Remifentanil in Extracorporeal Shock Wave Lithotripsy (ESWL)

Primary Purpose

Kidney Calculi

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Remifentanil
Remifentanil
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Calculi focused on measuring Remifentanil, Lithotripsy, Conscious Sedation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Policlinico Umberto I

Outcomes

Primary Outcome Measures

VAS score
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".

Secondary Outcome Measures

Full Information

First Posted
October 6, 2011
Last Updated
October 12, 2011
Sponsor
University of Roma La Sapienza
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1. Study Identification

Unique Protocol Identification Number
NCT01452880
Brief Title
Remifentanil in Extracorporeal Shock Wave Lithotripsy
Acronym
ESWL
Official Title
Total Intravenous Anaesthesia Using Remifentanil In Extracorporeal Shock Wave Lithotripsy (ESWL). Comparison of Two Dosages.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Calculi
Keywords
Remifentanil, Lithotripsy, Conscious Sedation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
228 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Remifentanil
Intervention Description
Remifentanil is an ultra-short-acting oppioid, which is quickly metabolized by unspecific blood and tissue esterases
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Intervention Description
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 Measure Information:
Title
VAS score
Description
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".
Time Frame
Vas score was monitored up to the end of surgery, for about forty minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Cannata, medical doctor
Organizational Affiliation
policlinico Umberto I Sapienza University of Rome
Official's Role
Principal Investigator
Facility Information:
Facility Name
Policlinico Umberto I
City
Rome
State/Province
Italy/RM
ZIP/Postal Code
00161
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
16037145
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.
Results Reference
result
Links:
URL
http://www.euroanesthesia.org/
Description
European Society of Anaesthesiology

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Remifentanil in Extracorporeal Shock Wave Lithotripsy

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