Status:
COMPLETED
Remifentanil in Extracorporeal Shock Wave Lithotripsy
Lead Sponsor:
University of Roma La Sapienza
Conditions:
Kidney Calculi
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
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 ...
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 suita...
Eligibility Criteria
Inclusion
- ASA (American Society of anaesthesiology) physical status between the I and class II
- Body mass index (BMI) between 18 and 30.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
228 Patients enrolled
Trial Details
Trial ID
NCT01452880
Start Date
January 1 2010
End Date
July 1 2010
Last Update
October 17 2011
Active Locations (1)
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1
Policlinico Umberto I
Rome, Italy/RM, Italy, 00161