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Postoperative Cognitive Function After Different Anesthetic Techniques in Obese Patients

18. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

90

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Tyrkia (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Tyrkia (Türkiye), 34899
        • Marmara University Faculty of Medicine Pendik Training and Research Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske 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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: Sevoflurane (Volatile Anesthetic)
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.
Eksperimentell: 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.
Legemiddel: Sevoflurane (Volatile Anesthetic)
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.
Eksperimentell: 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.
Legemiddel: propofol
Maintenance of total intravenous anesthesia using continuous propofol infusion under BIS monitoring.
Legemiddel: Remifentanil
Continuous remifentanil infusion was administered during maintenance of anesthesia according to study protocol.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Gaziantep City Hospital

Etterforskere

  • Hovedetterforsker: 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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

10. januar 2023

Primær fullføring (Faktiske)

20. juni 2023

Studiet fullført (Faktiske)

20. juni 2023

Datoer for studieregistrering

Først innsendt

13. juni 2026

Først innsendt som oppfylte QC-kriteriene

18. juni 2026

Først lagt ut (Faktiske)

24. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

24. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • MU-09.2022.744

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Individual participant data will not be made publicly available due to privacy and confidentiality considerations.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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