|
ISRCTN
|
ISRCTN73421343
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Propofol and remifentanil requirements after acute ethanol intake in clinical settings
|
|
Scientific title
|
|
|
Acronym
|
PRAECS
|
|
Serial number at source
|
N/A
|
|
Study hypothesis
|
Null hypothesis:Patients receiving intravenous ethanol would not require smaller doses of propofol and remifentanil for induction and maintenance of anaesthesia.
|
|
Lay summary
|
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
Greece
|
|
Disease/condition/study domain
|
Interaction of acute ethanol intravenous intake with propofol (general anesthetic) and remifentanil (opioid)
|
|
Participants - inclusion criteria
|
Female surgical patients on general anesthesia
|
|
Participants - exclusion criteria
|
Alcoholic patients, patients in abstinence
|
|
Anticipated start date
|
02/02/2004
|
|
Anticipated end date
|
07/06/2004
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
60
|
|
Interventions
|
Comparison of two groups (with different ethanol doses) versus control (no ethanol), regarding propofol and remifentanil requirements
|
|
Primary outcome measure(s)
|
Reduction of propofol and remifentanil requirements
|
|
Secondary outcome measure(s)
|
Degree of reduction, side-effects
|
|
Sources of funding
|
Theagenio Anticancer Hospital of Thessaloniki (Greece)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Fotis
Kanakoudis
|
|
Address
|
Korytsas 14
|
|
City/town
|
Thessaloniki
|
|
Zip/Postcode
|
55133
|
|
Country
|
Greece
|
|
Tel
|
+30 2310437531
|
|
Email
|
fkanak@otenet.gr
|
|
Sponsor
|
Theagenio Anticancer Hospital of Thessaloniki (Greece)
|
|
Address
|
Al. Symeonidis 2
|
|
City/town
|
Thessaloniki
|
|
Zip/Postcode
|
54007
|
|
Country
|
Greece
|
|
Tel
|
+30 2310898213
|
|
Email
|
amitragas@yahoo.com
|
|
Sponsor website:
|
http://www.theagenio.gr
|
|
Date applied
|
30/06/2005
|
|
Last edited
|
14/09/2009
|
|
Date ISRCTN assigned
|
08/07/2005
|