Clinical Predictors of Apnea-hypopnea During Propofol Sedation

Terminated

• Conditions: Sleep Apnea

• Registration Number: NCT01871259
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

The investigators will evaluate correlation between STOP scor and AHI(apnea hypopnea index) or eRDI and AHI. After then the investigators will compare AHI severity between high risk group and low risk group subgrouped according to STOP score or eRDI.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2008-11
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2013-06
• Study First Submitted: 2013-06-04
• Study First Submitted QC: 2013-06-05
• Last Update Submitted: 2013-06-05
• Study First Posted: 2013-06-06
• Last Update Posted: 2013-06-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 29

Inclusion Criteria

• Thirty four males who underwent spinal anaesthesia for transurethral resection of the bladder (TURB) or prostate (TURP) were enrolled in this studyInclusion criteria were American Society of Anaesthesiologists (ASA) physical status of 1-2, and ages of more than 40 years.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Apnea hypopnea index	1hour	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.