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
Scientific
Chariteplatz 1
Berlin
10117
Germany
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| Scientific title | |
| Study acronym | OSAS |
| Study objectives | Polysomnographic 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) studied | 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 |
| 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 study start date | 01/07/2006 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/07/2006 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- Germany
Study participating centre
Chariteplatz 1
Berlin
10117
Germany
10117
Germany
Sponsor information
Charite - University Medicine Berlin (Charite - Universitaetsmedizin Berlin) (Germany)
University/education
University/education
Chariteplatz 1
Berlin
10117
Germany
| Website | http://www.charite.de |
|---|---|
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
