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OpenTrials
Completed

NCT Number: NCT05717010

Is There a Risk of Perioperative Stroke Due to the Retraction Used During Anterior Cervical Discectomy?

In anterior cervical disc surgery, head and neck extansion position and, surgical retraction used while reaching the anterior surface of the cervical vertebra can be affect the carotid blood flow and constituting a risk for cerebral ischaemia. In this study, we planned to investigate the relationship between head position and retraction, cerebral oxygenation and postoperative cognitive functions in patients undergoing anterior cervical disc surgery.

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Key information

Conditions

Cervical Disc Disease Cervical Disc Herniation Cervical Stenosis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nevin Esra Gumus

Samsun, 55000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged 18-70 years
  • Preoperative Mini-Mental State Examination score of 27-30
  • Who were planned to undergo anterior cervical disc surgery under general anesthesia

Exclusion criteria

  • Patients with hypertension, severe pulmonary disease, anaemia, cardiac disease, ischaemic cerebrovascular disease, renal disease, hepatic disease, pregnancy, uncontrolled diabetes mellitus, stricture or obstruction in the carotid or vertebral arteries or
  • Body mass index (BMI) >30.

Treatment and study plan

Near infrared spectroscopy

Device

The Near Infrared Spectroscopy (NIRS) is the method used for monitorize the risk of the development of cerebral ischaemia while providing information about brain tissue oxygenation.

Primary outcomes

  1. Near-infrared spectroscopy (NIRS)

    Time frame: Intraoperative

    Evaluate the effect of head position and surgical retraction on brain oxygenization with NIRS. Near-infrared spectroscopy (NIRS) is a brain imaging method that measures light absorbance to calculate oxy-hemoglobin (oxy-HB) and deoxy-hemoglobin (deoxy-HB), which provides an indirect measure of brain activity, particularly in the frontal cortex.

Secondary outcomes

  1. Mini-Mental State Examination

    Time frame: 2 hours postoperative

    Evaluate the effect of head position and surgical retraction on cognitive functions with using mini-mental state examination . A Mini-Mental State Examination (MMSE) is a set of 30 questions that commonly use to check for cognitive impairment (problems with thinking, communication, understanding and memory)

Sponsors and collaborators

Lead sponsor

Samsun University

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 8, 2023
Registry last updated
Feb 8, 2023

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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