Clinical Predictors of Apnea-hypopnea During Propofol Sedation

Sleep Apnea Clinical Trial

— sleeposa  

Official title:

Clinical Predictors of Apnea-hypopnea During Propofol Sedation in Patients Undergoing Spinal Anaesthesia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01871259
• Other study ID #: sleeposa
• Status: Terminated
• Phase: N/A
• First received: June 4, 2013
• Last updated: June 5, 2013
• Start date: November 2008
• Est. completion date: November 2009

Study information

• Verified date: June 2013
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 70 Years

Eligibility

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.

Exclusion Criteria:

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes