Condition category
Not Applicable
Date applied
15/10/2009
Date assigned
29/10/2009
Last edited
29/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.icuheraklion.gr

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes