Intravenous Anesthesıa and Cognıtıve Functıon ın Spınal Surgery

NCT07701187 | Completed

• 1 other identifier: 2011-KAEK-25 2023/09-09
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the effect of these two different intravenous infusion techniques \[manuel controlled infusion (MCI) and Target controlled Infusion( TCI)\] on POCD. To assess POCD, the Mini Mental State Examination (MMSE ) and the Montreal Cognitive Assessment (MoCA ) will be used. MoCA and MMSE have high sensitivity and specificity for identifying patients with mild cognitive impairment who perform within the normal range. In a study by Meng et al., comparing target-controlled infusion and manual infusion of propofol anesthesia during electroconvulsive therapy, the randomized, controlled trial showed no significant difference in postelectroconvulsive therapy changes in MoCA scores in either group; however, they reported improvement in MoCA scores after 6 electroconvulsive therapy treatments in the MCI group, while deterioration occurred in the TCI group. Researchers found no studies investigating the effects of both infusion methods in spinal surgery and their impact on cognitive function, and they planned to evaluate the effects of the groups in their study.

Conditions

Postoperative Cognitive Dysfunction (POCD)

Keywords

target-controlled infusion; Manuel-controlled infüsion; propofol; Post-Operative Cognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

• Post-Operative Cognitive Dysfunction

  Montreal Cognitive Assessment (MoCA) scores Normally accepted threshold values: A score of 26 or higher on the MoCA (Montreal Cognitive Assessment) test For cognitive impairment: A decrease of at least 1-2 points on the MoCA is considered significant.

  preoperatively and 24 hours postoperatively at the patient's bedside

Secondary Outcomes (1)

• Evaluation of intraoperative anaesthezic consumption

  intraoperatıve

Study Arms (1)

target-controlled infusion group

EXPERIMENTAL

infusion via microprocessor-controlled infusion pumps operating according to pharmacokinetic algorithms (target-controlled infusion, TCI).

Device: Manuel controlled infusion group

Interventions

Manuel controlled infusion group DEVICE

infusion via manually controlled infusion pumps

Also known as: MCI

target-controlled infusion group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Turkish language proficiency,
• age (18-65 years),
• American Society of Anesthesiologists (ASA) I-III score,
• elective spinal surgery.

You may not qualify if:

• \- refusal to participate
• central nervous system disorders,
• use of antidepressants or antipsychotic medications,
• alcohol or drug use,
• illiteracy.

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

Study Sites (1)

Bursa yüksek ihtisas eğitim ve araştırma hastanesi BURSA, Bursa, Türkiye, BURSA, Bursa 16310, BURSA, Bursa

Bursa, Bursa, 16310, Turkey (Türkiye)

Location

Related Publications (1)

• Bayburt NS, Duruk Erkent FN, Guven A, Alkis N. Comparison of the Effects of Target-Controlled Versus Conventional Infusion Sedation on Recovery in Geriatric Patients Undergoing Diagnostic Cystoscopy. Turk J Anaesthesiol Reanim. 2026 Feb 9;54(1):40-48. doi: 10.4274/TJAR.2025.252107. Epub 2025 Oct 1.

  PMID: 40916451 BACKGROUND

MeSH Terms

Conditions

Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOCIATE PROFESSOR

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 14, 2026
• Study Start: September 22, 2023
• Primary Completion: September 22, 2024
• Study Completion: September 22, 2024
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)