Postoperative Cognitive Function After Different Anesthetic Techniques in Obese Patients
18. juni 2026 opdateret af: Gaziantep City Hospital
Effects of Low-Flow Sevoflurane, Normal-Flow Sevoflurane, and Total Intravenous Anesthesia on Postoperative Cognitive Function in Obese Patients Undergoing Laparoscopic Abdominal Surgery
Obese patients are at increased risk of postoperative cognitive dysfunction (POCD).
The effects of different anesthetic techniques on postoperative cognitive function remain controversial.
This prospective randomized study aimed to compare the effects of low-flow sevoflurane anesthesia, normal-flow sevoflurane anesthesia, and total intravenous anesthesia (TIVA) on postoperative cognitive function and recovery characteristics in obese patients undergoing elective laparoscopic abdominal surgery.
Cognitive function was assessed using the Mini-Mental State Examination (MMSE) before surgery, at postoperative 30 minutes, and on postoperative day 3.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Obesity is associated with physiological alterations that may increase the risk of postoperative cognitive dysfunction (POCD). The influence of anesthetic techniques on postoperative cognitive outcomes in obese patients remains uncertain.
This prospective randomized study was conducted in obese patients (BMI ≥30 kg/m²) aged 18-65 years undergoing elective laparoscopic abdominal surgery under general anesthesia. Patients were randomly assigned to one of three groups: low-flow sevoflurane anesthesia, normal-flow sevoflurane anesthesia, or total intravenous anesthesia (TIVA). Anesthetic depth was monitored using bispectral index (BIS) monitoring and maintained between 40 and 60 in all groups.
The primary objective was to compare postoperative cognitive function among the three anesthetic techniques using the Mini-Mental State Examination (MMSE). MMSE scores were evaluated preoperatively, at postoperative 30 minutes, and on postoperative day 3.
Secondary objectives included comparison of recovery characteristics, including eye-opening time, extubation time, Modified Aldrete Recovery Scores, and perioperative hemodynamic parameters.
The study was approved by the Marmara University Faculty of Medicine Clinical Research Ethics Committee (Approval No. 09.2022.744) and written informed consent was obtained from all participants before enrollment.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
90
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Istanbul
-
Istanbul, Istanbul, Tyrkiet (Türkiye), 34899
- Marmara University Faculty of Medicine Pendik Training and Research Hospital
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Inclusion Criteria:
- Age between 18 and 65 years
- Body mass index (BMI) ≥30 kg/m²
- ASA physical status I-III
- Scheduled for elective laparoscopic abdominal surgery
- Provision of written informed consent
Exclusion Criteria:
- History of psychiatric disease
- Dementia or known cognitive impairment
- Hearing or language disorders preventing MMSE assessment
- Refusal to participate
- Conversion from laparoscopic to open surgery
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Low-Flow Sevoflurane
Patients received sevoflurane anesthesia with a fresh gas flow of 1 L/min during maintenance of anesthesia.
Anesthetic depth was maintained with BIS values between 40 and 60.
|
Maintenance of general anesthesia with sevoflurane inhalation.
Patients were assigned to either low-flow (1 L/min) or normal-flow (3 L/min) fresh gas flow anesthesia protocols.
|
|
Eksperimentel: Normal-Flow Sevoflurane
Patients received sevoflurane anesthesia with a fresh gas flow of 3 L/min during maintenance of anesthesia.
Anesthetic depth was maintained with BIS values between 40 and 60.
|
Maintenance of general anesthesia with sevoflurane inhalation.
Patients were assigned to either low-flow (1 L/min) or normal-flow (3 L/min) fresh gas flow anesthesia protocols.
|
|
Eksperimentel: Total Intravenous Anesthesia (TIVA)
Patients received total intravenous anesthesia with propofol and remifentanil infusion.
Anesthetic depth was maintained with BIS values between 40 and 60.
|
Maintenance of total intravenous anesthesia using continuous propofol infusion under BIS monitoring.
Continuous remifentanil infusion was administered during maintenance of anesthesia according to study protocol.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mini-Mental State Examination (MMSE) Score
Tidsramme: Preoperative, postoperative 30 minutes, and postoperative day 3
|
Postoperative cognitive function assessed using the Mini-Mental State Examination (MMSE).
|
Preoperative, postoperative 30 minutes, and postoperative day 3
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Eye Opening Time
Tidsramme: End of surgery
|
Time from discontinuation of anesthetic administration to spontaneous eye opening
|
End of surgery
|
|
Extubation Time
Tidsramme: End of surgery
|
Time from discontinuation of anesthetic administration to tracheal extubation.
|
End of surgery
|
|
Modified Aldrete Recovery Score
Tidsramme: Postoperative recovery period
|
Recovery status assessed using the Modified Aldrete Score.
|
Postoperative recovery period
|
|
heart rate
Tidsramme: During surgery
|
patient's intraoperative measured heart rate
|
During surgery
|
|
mean arterial pressure
Tidsramme: during surgery
|
patient's intraoperative measured mean arterial pressure
|
during surgery
|
|
oxygen saturation
Tidsramme: During surgery
|
oxygen saturation of the patient will be recorded
|
During surgery
|
|
end-tidal carbon dioxide
Tidsramme: During surgery
|
end-tidal carbon dioxide of the patient will be recorded
|
During surgery
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Ahmet Tunca, MD, Department of Anesthesiology and Reanimation, Gaziantep City Hospital
- Studiestol: Seniyye Ü Zengin, MD, Department of Anesthesiology and Reanimation, Marmara University Faculty of Medicine, Pendik Training and Research Hospital
- Studieleder: Meliha O Ergün, MD, Department of Anesthesiology and Reanimation, Marmara University Faculty of Medicine, Pendik Training and Research Hospital
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
10. januar 2023
Primær færdiggørelse (Faktiske)
20. juni 2023
Studieafslutning (Faktiske)
20. juni 2023
Datoer for studieregistrering
Først indsendt
13. juni 2026
Først indsendt, der opfyldte QC-kriterier
18. juni 2026
Først opslået (Faktiske)
24. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Ernæringsforstyrrelser
- Overernæring
- Kropsvægt
- Overvægtig
- Patologiske tilstande, tegn og symptomer
- Ernæringsmæssige og metaboliske sygdomme
- Tegn og symptomer
- Fedme
- Organiske kemikalier
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Ethers
- Kulbrinter
- Kulbrinter, cyklisk
- Syrer, acyklisk
- Carboxylsyrer
- Kulbrinter, aromatisk
- Piperidiner
- Fenoler
- Benzenderivater
- Kulbrinter, halogeneret
- Kulbrinter, fluoreret
- Propionater
- Methylethere
- Remifentanil
- Sevofluran
- Propofol
Andre undersøgelses-id-numre
- MU-09.2022.744
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
Individual participant data will not be made publicly available due to privacy and confidentiality considerations.
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