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Clinical Trials/NCT07701187
NCT07701187CompletedNot Applicable

The Effect of Two Dıfferent Intravenous Anesthesıa Technıques on Cognıtıve Functıons ın Spınal Surgery

Bursa Yuksek Ihtisas Training and Research Hospital1 site in 1 country128 target enrollmentStarted: September 22, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
128
Locations
1
Primary Endpoint
Post-Operative Cognitive Dysfunction

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

target-controlled infusion group

Experimental

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

Intervention: Manuel controlled infusion group (Device)

Outcomes

Primary Outcomes

Post-Operative Cognitive Dysfunction

Time Frame: preoperatively and 24 hours postoperatively at the patient's bedside

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.

Secondary Outcomes

  • Evaluation of intraoperative anaesthezic consumption(intraoperatıve)

Investigators

Sponsor
Bursa Yuksek Ihtisas Training and Research Hospital
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

sermın emınoglu

ASSOCIATE PROFESSOR

Bursa Yuksek Ihtisas Training and Research Hospital

Study Sites (1)

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