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

Completed

• Conditions: Cervical Disc Disease; Cervical Disc Herniation; Cervical Stenosis
• Interventions: Device: Near infrared spectroscopy

• Registration Number: NCT05717010
• Lead Sponsor: Samsun University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-01
• Primary Completion: 2021-08-01
• Study Completion: 2021-08-01
• Study First Submitted: 2022-12-16
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-30
• Last Update Submitted: 2023-01-30
• Study First Posted: 2023-02-08
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group self-retaining retractor	Near infrared spectroscopy	Patients used self-retaining retractor for surgery
Group Hand-held retractor	Near infrared spectroscopy	Patients used hand held retractor for surgery

Primary Outcome Measures

Name	Time	Method
Near-infrared spectroscopy (NIRS)	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 Outcome Measures

Name	Time	Method
Mini-Mental State Examination	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)

Trial Locations

Locations (1)

Nevin Esra Gumus; 🇹🇷 Samsun, Turkey