Remifentanil in Extracorporeal Shock Wave Lithotripsy

NCT01452880 | Completed Phase 4 DMC

• 1 other identifier: francesco cannata
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Calculi

Keywords

Remifentanil; Lithotripsy; Conscious Sedation

Outcome Measures

Primary Outcomes (1)

• 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".

  Vas score was monitored up to the end of surgery, for about forty minutes

Interventions

Remifentanil DRUG

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA (American Society of anaesthesiology) physical status between the I and class II
• Body mass index (BMI) between 18 and 30.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Policlinico Umberto I

Rome, Italy/RM, 00161, Italy

Location

Related Publications (1)

• 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.

  PMID: 16037145 RESULT

Related Links

• European Society of Anaesthesiology

MeSH Terms

Conditions

Kidney Calculi

Interventions

Remifentanil

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Francesco Cannata, medical doctor

  policlinico Umberto I Sapienza University of Rome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor

Study Record Dates

• First Submitted: October 6, 2011
• First Posted: October 17, 2011
• Study Start: January 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: October 17, 2011

Record last verified: 2011-10

Locations

IT (1)