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Near Infrared Spectroscopy for Detection of Cerebral Desaturation After Positioning for Neurosurgical Procedures

Near Infrared Spectroscopy for Detection of Cerebral Desaturation After Positioning for Neurosurgical Procedure

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03093311
Enrollment
100
Registered
2017-03-28
Start date
2017-04-01
Completion date
2019-06-30
Last updated
2019-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Dysfunction, Patient Positioning

Keywords

Near-Infrared Spectroscopy, Neurosurgical Procedures, Cognitive Dysfunction

Brief 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.

Detailed 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.

Interventions

OTHERNIRS 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.

Sponsors

University Hospital Hradec Kralove
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Reduction of incidence of postoperative cognitive dysfunction (POCD)1 day before operation and the fifth´dayAddenbrooke test

Secondary

MeasureTime frameDescription
Operative position of patientfirst 30 minutesIn grades from neutral position
Age of patientsthe first 5 minutes18 to 79
Level of exhaled carbon dioxideevery 5 minutesIn torr
Type and duration of procedure10 minutes after procedureIn minutes
Dose of catecholamines5 minutes after procedureIn microgramms per kg per minute

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026