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

NCT ID: NCT05717010

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-01

Study Completion Date

2021-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Cervical Disc Disease Cervical Stenosis Cervical Disc Herniation

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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Group self-retaining retractor

Patients used self-retaining retractor for surgery

Near infrared spectroscopy

Intervention Type 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

Patients used hand held retractor for surgery

Near infrared spectroscopy

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsun University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Samsun Üniversitesi

Role: STUDY_CHAIR

Samsun University

Locations

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Nevin Esra Gumus

Samsun, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 32219565 (View on PubMed)

Other Identifiers

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Samsun University (SamsunU)

Identifier Type: -

Identifier Source: org_study_id

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