Remifentanil in Extracorporeal Shock Wave Lithotripsy

NCT ID: NCT01452880

Last Updated: 2011-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 228 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2010-07-31

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.

Conditions

Kidney Calculi

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Remifentanil

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

Intervention Type: DRUG

Remifentanil

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Francesco Cannata

medical doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francesco Cannata, medical doctor

Role: PRINCIPAL_INVESTIGATOR

policlinico Umberto I Sapienza University of Rome

Locations

Policlinico Umberto I

Rome, Italy/RM, Italy

Countries

Italy

References

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.

Reference Type: RESULT

PMID: 16037145 (View on PubMed)

Related Links

http://www.euroanesthesia.org/

European Society of Anaesthesiology

Other Identifiers

francesco cannata

Identifier Type: -

Identifier Source: org_study_id