Remifentanil in Extracorporeal Shock Wave Lithotripsy (ESWL)

October 12, 2011 updated by: Francesco Cannata, University of Roma La Sapienza

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

228

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Italy/RM
      • Rome, Italy/RM, Italy, 00161
        • Policlinico Umberto I

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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".
Vas score was monitored up to the end of surgery, for about forty minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Investigators

  • Principal Investigator: Francesco Cannata, medical doctor, policlinico Umberto I Sapienza University of Rome

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

July 1, 2010

Study Completion (ACTUAL)

July 1, 2010

Study Registration Dates

First Submitted

October 6, 2011

First Submitted That Met QC Criteria

October 12, 2011

First Posted (ESTIMATE)

October 17, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

October 17, 2011

Last Update Submitted That Met QC Criteria

October 12, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • francesco cannata

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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