Glostrup Hospital
Copenhagen, Glostrup kommune, 2600, Denmark
Completed
NCT Number: NCT01760369
Study of the: Effect of Head Rotation in Prone Position on Regional Cerebral Oxygen Saturation.
The purpose of this study is to determine whether head rotation in prone positon affects regional cerebral oxygenation (rSO2)in anesthetized patients undergoing lower back surgery.
Completed
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Notify MeKey information
Age range
18 year–80 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Lower back surgery
- Age [18-80]
- ASA group I-III
- free and painless movement of the neck (including flexion, extension and rotation)
Exclusion criteria
- Pain during neck movement as mentioned under inclusion criteria.
- known history of cervical spine pathology or pathology of central nervous system including cerebrovascular disease
- any stenosis of the carotid vessels or known symptoms associated with such
- BMI > 35
Treatment and study plan
Primary outcomes
-
Change in regional cerebral oxygenation (rSO2)
Time frame: 1 day
Before, during and immediately after awaking from anesthesia
Secondary outcomes
-
Post anesthetic complications
Time frame: 1 day
During stay at the post anesthetic care unit. Any new neurological symptoms, pain from the neck, visual symptoms etc.
Sponsors and collaborators
Lead sponsor
Glostrup University Hospital, Copenhagen
Other
Registry information
Official study title
Observation Study of the: Effect of Head Rotation in Prone Position on Regional Cerebral Oxygen Saturation (rSO2) in Anesthetized Patients.
Acronym: NIRS
Important dates
- Study start
- 2012
- Primary completion
- 2013
- Study completion
- 2013
- First posted
- Jan 4, 2013
- Registry last updated
- Nov 14, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.