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

January 30, 2023 updated by: Samsun University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Samsun, Turkey, 55000
        • Nevin Esra Gumus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing cervical disc surgery

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group self-retaining retractor
Patients used self-retaining retractor for surgery
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.
Group Hand-held retractor
Patients used hand held retractor for surgery
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
2 hours postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsun University

Investigators

  • Study Chair: Samsun Üniversitesi, Samsun University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2020

Primary Completion (ACTUAL)

August 1, 2021

Study Completion (ACTUAL)

August 1, 2021

Study Registration Dates

First Submitted

December 16, 2022

First Submitted That Met QC Criteria

January 30, 2023

First Posted (ACTUAL)

February 8, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

January 30, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Samsun University (SamsunU)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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