Safety of perioperative patients with obstructive sleep apnoea

ISRCTN	ISRCTN37803178
DOI	https://doi.org/10.1186/ISRCTN37803178
Protocol serial number	EA1/016/06
Sponsor	Charite - University Medicine Berlin (Charite - Universitaetsmedizin Berlin) (Germany)
Funder	Charite - University Medicine Berlin (Charite - Universitaetsmedizin Berlin) (Germany)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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
Key secondary outcome measure(s)	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
Completion date	31/12/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

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