Effect of propofol on sleep quality of critically ill patients

ISRCTN	ISRCTN72847182
DOI	https://doi.org/10.1186/ISRCTN72847182
Protocol serial number	N/A
Sponsor	Cretan Critical Care Society (Greece)
Funder	Cretan Critical Care Society (Greece)

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

Intensive Care Unit
University Hospital of Heraklion
Crete
71110
Greece

Phone	+30 2810 392 585
Email	konde@med.uoc.gr

Study information

Primary study design	Interventional
Study design	Randomised placebo-controlled cross-over trial
Secondary study design	Randomised controlled trial
Study type	Participant 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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Propofol
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	05/10/2010

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes