Safety of perioperative patients with obstructive sleep apnoea

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN37803178

Enrollment

Registered

2008-01-23

Start date

2006-07-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive sleep aponea Nervous System Diseases Obstructive sleep aponea

Interventions

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 R

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026