Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
EA1/016/06
Study information
Scientific title
Acronym
OSAS
Study hypothesis
Polysomnographic parameters in patients with obstructive sleep apnoea are influenced by the type of surgery and the type of anaesthesia.
Ethics approval
Ethics approval received from the Charité - Berlin Medical University Ethics Committee on the 18th May 2006 (ref: EA1/016/06).
Study design
Randomised controlled 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
Obstructive sleep aponea
Intervention
Group 1: 20 patients with surgery with general anaesthesia
Group 2: 20 patients with surgery with regional anaesthesia
Group 3: 20 patients with surgery on the upper airway with general anaesthesia
Randomisation of participants will be carried out between groups 1 and 2. There is no randomisation in group 3.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Apnoea-hypopnoea index, based on the following:
1. Continuous polysomnographic measurement. This will be carried out at the following timepoints:
1.1. The night before surgery from 23:00 pm to 7:00 am
1.2. For 2 hours in the recovery room after extubation
1.3. After returning from the recovery room to the ward, until 7:00 am next day
2. The patients will be asked to rate the intensity/recreative power of the night sleep on a scale, from 1 (not recreative) to 5 (very recreative) the first and second morning 7:00 am
Secondary outcome measures
1. Patient satisfaction, based on the following:
1.1. The patients will be asked to rate his contentedness with the anaesthesia on a scale, from 1 (very content) to 5 (not content) the next morning after surgery
1.2. The patients will be asked to rate the pain on a scale from 0 (no pain) to 10 (strongest pain) at the following timepoints:
1.2.1. At the beginning of the anaesthesia
1.2.2. Immediately after extubation
1.2.3. After the first hour in the recovery room
1.2.4. After the second hour in the recovery room
1.2.5. Next morning after surgery
2. Heart rate and blood pressure, measured as part of the continuous polysomnographic measurement (see primary outcome measures)
3. Circulating mediators
4. Validity of screening
Overall trial start date
01/07/2006
Overall trial end date
31/12/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Obstructive sleep apnoea (the Epworth Sleepiness Scale [ESS] score greater than 9)
2. Elective surgery with either general or regional anaesthesia, or airway surgery
3. Aged greater than 18 years, either sex
4. American Society of Anaesthesiologists (ASA) classification I - III
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Significant cardiovascular or pulmonary disease
2. Significant liver or renal disease
3. Significant psychiatric disease rendering the subject unable to participate in the trial
4. Drug dependency
5. Chronic opioid therapy
6. Chronic BiPAP (Bi-level Positive Airway Pressure) ventilator therapy
Recruitment start date
01/07/2006
Recruitment end date
31/12/2008
Locations
Countries of recruitment
Germany
Trial participating centre
Chariteplatz 1
Berlin
10117
Germany
Sponsor information
Organisation
Charite - University Medicine Berlin (Charite - Universitaetsmedizin Berlin) (Germany)
Sponsor details
Chariteplatz 1
Berlin
10117
Germany
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Charite - University Medicine Berlin (Charite - Universitaetsmedizin Berlin) (Germany)
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