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Completed

NCT Number: NCT03093311

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Hradec Kralove

Hradec Králové, 50005, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

NIRS based protocol

Other

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.

Primary outcomes

  1. Reduction of incidence of postoperative cognitive dysfunction (POCD)

    Time frame: 1 day before operation and the fifth´day

    Addenbrooke test

Secondary outcomes

  1. Operative position of patient

    Time frame: first 30 minutes

    In grades from neutral position

  2. Age of patients

    Time frame: the first 5 minutes

    18 to 79

  3. Level of exhaled carbon dioxide

    Time frame: every 5 minutes

    In torr

  4. Type and duration of procedure

    Time frame: 10 minutes after procedure

    In minutes

  5. Dose of catecholamines

    Time frame: 5 minutes after procedure

    In microgramms per kg per minute

Sponsors and collaborators

Lead sponsor

University Hospital Hradec Kralove

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Mar 28, 2017
Registry last updated
Oct 1, 2019

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.

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