ESWL: Remifentanil in Extracorporeal Shock Wave Lithotripsy

Sponsor

University of Roma La Sapienza (Other)

Overall Status

Completed

CT.gov ID

NCT01452880

Collaborator

(none)

228

Enrollment

Location

5.9

Duration (Months)

38.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Calculi	Drug: Remifentanil 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 Design

Study Type:

Interventional

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 :

Jan 1, 2010

Actual Primary Completion Date :

Jul 1, 2010

Actual Study Completion Date :

Jul 1, 2010

Outcome Measures

Primary Outcome Measures

VAS score [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".

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.