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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03093311
Other study ID # UHHradecKralove 2017/01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2017
Est. completion date June 30, 2019

Study information

Verified date September 2019
Source University Hospital Hradec Kralove
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The occurrence of postoperative cognitive dysfunction (POCD) might be related to intraoperative cerebral desaturation. Positioning for neurosurgical procedures are associated with head rotation, elevation, flexion or extention that may affect blood brain inflow and outflow. Anatomical variations of Willis circle could affect the cerebral blood flow in extreme head position with the development of cerebral ischemia or functional changes of brain. Investigators suppose that detection of cerebral tissue desaturation and its prompt correction could modify the occurence of POCD after these procedures.


Description:

Standardized anesthesia and perioperative care will be provided to all patiens with positioning for neurosurgical or spinal procedures, where the head is elevated, extended. flected or rotated. In group A before the start of general anesthesia, the baseline level of cerebral tissue oxygenation (rScO2) will be measured using the near-infrared spectroscopy NIRS (Invivo Medtronic) . Continuous measurement of rScO2 will be used for detection of cerebral tissue desaturation. Each desaturation episode will be managed according to a standardized protocol - correction of extreme head position will be followed by optimalisation of mean arterial pressure (MAP), arterial hemoglobin oxygen saturation, end tidal carbon dioxide concentration and a level of hemoglobine concentration. In group B neither measurement of rScO2 nor interventions are provided. Cognitive dysfunction will be assessed by Adenbrooke test before operation and on the fifth postoperative day.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date June 30, 2019
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Glasgow Coma Scale 15, American Society of Anaesthesiologists (ASA) Physical Status Classification System Grade I-III, patient positioning with elevation, rotation, flexion or extention of head

Exclusion Criteria:

- Inability to past the Addenbrooke test, postoperative ventilation, awake phase during surgery, lung disease with retention of carbon dioxide, neurological disease before surgery (aphasia, paresis, blindness, deafness)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
NIRS based protocol
Each desaturation episode will be managed according to a standardized protocol - correction of extreme head position will be followed by optimisation of mean arterial pressure (MAP), arterial hemoglobin oxygen saturation, end tidal carbon dioxide concentration and a level of hemoglobine concentration.

Locations

Country Name City State
Czechia University Hospital Hradec Kralove Hradec Kralove

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Hradec Kralove

Country where clinical trial is conducted

Czechia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reduction of incidence of postoperative cognitive dysfunction (POCD) Addenbrooke test 1 day before operation and the fifth´day
Secondary Operative position of patient In grades from neutral position first 30 minutes
Secondary Age of patients 18 to 79 the first 5 minutes
Secondary Level of exhaled carbon dioxide In torr every 5 minutes
Secondary Type and duration of procedure In minutes 10 minutes after procedure
Secondary Dose of catecholamines In microgramms per kg per minute 5 minutes after procedure
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