Safety of perioperative patients with obstructive sleep apnoea

ISRCTN ISRCTN37803178
DOI https://doi.org/10.1186/ISRCTN37803178
Secondary identifying numbers EA1/016/06
Submission date
22/10/2007
Registration date
23/01/2008
Last edited
23/01/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nervous System Diseases
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

Prof Thomas Volk
Scientific

Chariteplatz 1
Berlin
10117
Germany

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet.
Scientific title
Study acronymOSAS
Study objectivesPolysomnographic parameters in patients with obstructive sleep apnoea are influenced by the type of surgery and the type of anaesthesia.
Ethics approval(s)Ethics approval received from the Charité - Berlin Medical University Ethics Committee on the 18th May 2006 (ref: EA1/016/06).
Health condition(s) or problem(s) studiedObstructive sleep aponea
InterventionGroup 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 typeOther
Primary outcome measureApnoea-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 measures1. 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 study start date01/07/2006
Completion date31/12/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants60
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/07/2006
Date of final enrolment31/12/2008

Locations

Countries of recruitment

  • Germany

Study participating centre

Chariteplatz 1
Berlin
10117
Germany

Sponsor information

Charite - University Medicine Berlin (Charite - Universitaetsmedizin Berlin) (Germany)
University/education

Chariteplatz 1
Berlin
10117
Germany

Website http://www.charite.de
ROR logo "ROR" https://ror.org/001w7jn25

Funders

Funder type

University/education

Charite - University Medicine Berlin (Charite - Universitaetsmedizin Berlin) (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan