CompletedNot Applicable

Intravenous Anesthesıa and Cognıtıve Functıon ın Spınal Surgery

Turkey (Türkiye)128 participantsStarted 2023-09-22

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Post-Operative Cognitive Dysfunction

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

Trial details

NCT IDNCT07701187

SponsorBursa Yuksek Ihtisas Training and Research Hospital

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2024-09-22

View on ClinicalTrials.gov More Postoperative Cognitive Dysfunction (POCD) trials