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Remifentanil in Extracorporeal Shock Wave Lithotripsy

Total Intravenous Anaesthesia Using Remifentanil In Extracorporeal Shock Wave Lithotripsy (ESWL). Comparison of Two Dosages.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01452880
Acronym
ESWL
Enrollment
228
Registered
2011-10-17
Start date
2010-01-31
Completion date
2010-07-31
Last updated
2011-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Calculi

Keywords

Remifentanil, Lithotripsy, Conscious Sedation

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.

Interventions

DRUGRemifentanil

Remifentanil is an ultra-short-acting oppioid, which is quickly metabolized by unspecific blood and tissue esterases

Sponsors

University of Roma La Sapienza
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
VAS scoreVas score was monitored up to the end of surgery, for about forty minutesBefore 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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026