Effect of propofol on sleep quality of critically ill patients
| ISRCTN | ISRCTN72847182 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72847182 |
| Secondary identifying numbers | N/A |
- Submission date
- 15/10/2009
- Registration date
- 29/10/2009
- Last edited
- 29/10/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
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 Eumorfia Kondili
Scientific
Scientific
Intensive Care Unit
University Hospital of Heraklion
Crete
71110
Greece
| Phone | +30 2810 392 585 |
|---|---|
| konde@med.uoc.gr |
Study information
| Study design | Randomised placebo-controlled cross-over trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Effect of propofol on sleep quality of critically ill patients: a randomised placebo controlled cross-over trial |
| Study acronym | Propofol vs Placebo |
| Study objectives | To assess the effect of propofol on sleep quality of mechanically ventilated critically ill patients. |
| Ethics approval(s) | Ethics Committee of University Hospital of Heraklion, Crete approved on the ... (ref: 11868) |
| Health condition(s) or problem(s) studied | Critically ill patients |
| Intervention | Each patient will be studied on two consecutive nights (from 9:00 pm to 7:00 am). In each patient two nights polysomnography studies will be performed with or without propofol in random order. Propofol will be administered via continuous infusion. The rate (mc/Kgr/min) of sedation will be such as to achieve a score of 3 on the Ramsay Scale (response to commands) with no changes in the infusion rate during the study time. Single doses of sedatives or changes in the rate of infusion of sedatives will be not permitted during the study or for 4 hours before the study. Patients in whom the requirements for sedation as judged by the primary physician increased during the night will be excluded for further study and the study will be terminated at that point. The Ramsay Scale will be re-evaluated at the beginning (9:00pm) at the middle (2:00pm) and end (7:00am) of the study. Patients will be followed up until their discharge from the hospital. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Propofol |
| Primary outcome measure | 1. Effect of propofol on sleep quality, measured immediately after each study night 2. Sleep architecture, scored manually by an expert physician not involved in the study. 3. Central apnoeas, arousals and awakenings, defined using standard criteria 4. Total sleep fragmentation, calculated as the sum of arousals and awakenings per hour of sleep |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 20/10/2009 |
| Completion date | 05/10/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 10 |
| Key inclusion criteria | 1. Critically ill patients, on mechanical ventilation for at least 48 hours, haemodynamically stable 2.Ventilated on assist mode 3. No respiratory distress 4. Aged between 18 and 85 years, inclusive, either sex |
| Key exclusion criteria | 1. Aged less than 18 and greater than 85 years 2. Severe haemodynamic instability 3. Pregnancy 4. End stage disease 5. Respiratory distress 6. Acute brain injury |
| Date of first enrolment | 20/10/2009 |
| Date of final enrolment | 05/10/2010 |
Locations
Countries of recruitment
- Greece
Study participating centre
Intensive Care Unit
Crete
71110
Greece
71110
Greece
Sponsor information
Cretan Critical Care Society (Greece)
Research organisation
Research organisation
Intensive Care Unit
University Hospital of Heraklion
Crete
71110
Greece
| Phone | +30 2810 392 636 |
|---|---|
| georgop@med.uoc.gr | |
| Website | http://www.icuheraklion.gr |
Funders
Funder type
Research organisation
Cretan Critical Care Society (Greece)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
