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

Cervical Disc Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05717010
• Other study ID #: Samsun University (SamsunU)
• Status: Completed
• Start date: August 1, 2020
• Est. completion date: August 1, 2021

Study information

• Verified date: January 2023
• Source: Samsun University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: August 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Disc Disease
• Cervical Disc Herniation
• Cervical Stenosis
• Intervertebral Disc Displacement

Intervention

Device:
• Near infrared spectroscopy
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.

Locations

Country	Name	City	State
Turkey	Nevin Esra Gumus	Samsun

Sponsors (1)

Lead Sponsor	Collaborator
Samsun University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Smarius BJA, Breugem CC, Boasson MP, Alikhil S, van Norden J, van der Molen ABM, de Graaff JC. Effect of hyperextension of the neck (rose position) on cerebral blood oxygenation in patients who underwent cleft palate reconstructive surgery: prospective co — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Near-infrared spectroscopy (NIRS)	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.	Intraoperative
Secondary	Mini-Mental State Examination	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)	2 hours postoperative