Contact information
Type
Scientific
Primary contact
Dr Eumorfia Kondili
ORCID ID
Contact details
Intensive Care Unit
University Hospital of Heraklion
Crete
71110
Greece
+30 2810 392 585
konde@med.uoc.gr
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effect of propofol on sleep quality of critically ill patients: a randomised placebo controlled cross-over trial
Acronym
Propofol vs Placebo
Study hypothesis
To assess the effect of propofol on sleep quality of mechanically ventilated critically ill patients.
Ethics approval
Ethics Committee of University Hospital of Heraklion, Crete approved on the ... (ref: 11868)
Study design
Randomised placebo-controlled cross-over trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
20/10/2009
Overall trial end date
05/10/2010
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
10
Participant 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
Recruitment start date
20/10/2009
Recruitment end date
05/10/2010
Locations
Countries of recruitment
Greece
Trial participating centre
Intensive Care Unit
Crete
71110
Greece
Sponsor information
Organisation
Cretan Critical Care Society (Greece)
Sponsor details
Intensive Care Unit
University Hospital of Heraklion
Crete
71110
Greece
+30 2810 392 636
georgop@med.uoc.gr
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Cretan Critical Care Society (Greece)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list