Clinical Predictors of Apnea-hypopnea During Propofol Sedation

NCT01871259 | Terminated DMC

• 1 other identifier: sleeposa
• Study Type: observational
• Target: 29
• Locations: 0 countries
• Sites: N/A

Brief Summary

To relate two different predictive values of sleep apnea: the STOP score (snoring while sleeping, daytime tiredness, observed breathing stoppages, and high blood pressure) and the estimated respiratory disturbance index (eRDI) with the occurrence of apnea-hypopnea during propofol sedation,thirty four middle-aged male patients who underwent urologic surgery under spinal anaesthesia will be enrolled. Before surgery, patients will be asked to complete a STOP-questionnaire. The eRDI will be calculated using the modified Mallampati's grade, tonsil grade, and the body mass index. After performing spinal anaesthesia, propofol will be infused and adjusted to BIS 70-75. An ApneaLinkTM, which measures airflow through a nasal cannula, will be then applied to estimate the level of apnea-hypopnea.

Conditions

Sleep Apnea

Keywords

Sedation, sleep apnea, propofol

Outcome Measures

Primary Outcomes (1)

• Apnea hypopnea index

  After surgery, an ApneaLinkTM was connected to a personal computer to record and auto-analyze AHIs. Aopnea was defined as a cessation of airflow for 10s or longer. Hypopnea was defined as a greater than 50% reduction in airflow for 10s or longer. AHI was defined as the number of aopnea and hypopnea incidents per hour.

  1hour

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We expected a correlation coefficient of \~0.5 in this study, which meant that for a level of significance of 5% and a power of 80%, we required 29 analyzable subjects. Based on a predicted exclusion rate of 15%, 34 patients were included.

You may not qualify if:

• Patients with electrocardiographic or simple chest radiographic abnormalities or who had taken medication that could affect their sleep patterns were excluded.

Sponsors & Collaborators

• Samsung Medical Center: lead

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Jeong Jin Lee, Professor

  : Department of Anaesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: June 4, 2013
• First Posted: June 6, 2013
• Study Start: November 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: June 6, 2013

Record last verified: 2013-06