Condition category
Nervous System Diseases
Date applied
22/10/2007
Date assigned
23/01/2008
Last edited
23/01/2008
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

Prof Thomas Volk

ORCID ID

Contact details

Chariteplatz 1
Berlin
10117
Germany

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 measures

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

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

http://www.charite.de

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes