Safety of perioperative patients with obstructive sleep apnoea

Completed

• Conditions: Obstructive sleep aponea; Nervous System Diseases

• Registration Number: ISRCTN37803178
• Lead Sponsor: Charite - University Medicine Berlin (Charite - Universitaetsmedizin Berlin) (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-23
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Apnoea-hypopnoea index, based on the following: <br>1. Continuous polysomnographic measurement. This will be carried out at the following timepoints:<br>1.1. The night before surgery from 23:00 pm to 7:00 am<br>1.2. For 2 hours in the recovery room after extubation<br>1.3. After returning from the recovery room to the ward, until 7:00 am next day <br>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

Name	Time	Method
1. Patient satisfaction, based on the following: <br>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<br>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:<br>1.2.1. At the beginning of the anaesthesia<br>1.2.2. Immediately after extubation<br>1.2.3. After the first hour in the recovery room<br>1.2.4. After the second hour in the recovery room<br>1.2.5. Next morning after surgery<br>2. Heart rate and blood pressure, measured as part of the continuous polysomnographic measurement (see primary outcome measures)<br>3. Circulating mediators <br>4. Validity of screening