Propofol and remifentanil requirements after acute ethanol intake in clinical settings
| ISRCTN | ISRCTN73421343 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73421343 |
| Protocol serial number | N/A |
| Sponsor | Theagenio Anticancer Hospital of Thessaloniki (Greece) |
| Funder | Theagenio Anticancer Hospital of Thessaloniki (Greece) |
- Submission date
- 30/06/2005
- Registration date
- 08/07/2005
- Last edited
- 14/09/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Fotis Kanakoudis
Scientific
Scientific
Korytsas 14
Thessaloniki
55133
Greece
| Phone | +30 2310437531 |
|---|---|
| fkanak@otenet.gr |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | PRAECS |
| Study objectives | Null hypothesis:Patients receiving intravenous ethanol would not require smaller doses of propofol and remifentanil for induction and maintenance of anaesthesia. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Interaction of acute ethanol intravenous intake with propofol (general anesthetic) and remifentanil (opioid) |
| Intervention | Comparison of two groups (with different ethanol doses) versus control (no ethanol), regarding propofol and remifentanil requirements |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Propofol, remifentanil and acute ethanol |
| Primary outcome measure(s) |
Reduction of propofol and remifentanil requirements |
| Key secondary outcome measure(s) |
Degree of reduction, side-effects |
| Completion date | 07/06/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 60 |
| Key inclusion criteria | Female surgical patients on general anesthesia |
| Key exclusion criteria | Alcoholic patients, patients in abstinence |
| Date of first enrolment | 02/02/2004 |
| Date of final enrolment | 07/06/2004 |
Locations
Countries of recruitment
- Greece
Study participating centre
Korytsas 14
Thessaloniki
55133
Greece
55133
Greece
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
