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

NCT05717010 | Completed

• 1 other identifier: Samsun University (SamsunU)
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cervical Disc Disease; Cervical Stenosis; Cervical Disc Herniation

Keywords

Cerebral blood oxygenation; Near infrared spectroscopy; Cervical disc disease; Cervical microsurgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Mini-Mental State Examination

  2 hours postoperative

Study Arms (2)

Group self-retaining retractor

Patients used self-retaining retractor for surgery

Device: Near infrared spectroscopy

Group Hand-held retractor

Patients used hand held retractor for surgery

Device: Near infrared spectroscopy

Interventions

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.

Group Hand-held retractor; Group self-retaining retractor

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing cervical disc surgery

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samsun University: lead

Study Sites (1)

Nevin Esra Gumus

Samsun, 55000, Turkey (Türkiye)

Location

Related 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 cohort study using near-infrared spectroscopy. Clin Oral Investig. 2020 Aug;24(8):2909-2918. doi: 10.1007/s00784-019-03157-8. Epub 2020 Mar 26.

  PMID: 32219565 RESULT

MeSH Terms

Interventions

Spectroscopy, Near-Infrared

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Samsun Üniversitesi

  Samsun University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2022
• First Posted: February 8, 2023
• Study Start: August 1, 2020
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: February 8, 2023

Record last verified: 2023-01

Locations

TU (1)