Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Effects of Standard and Modified Z-Trendelenburg Positions on Cerebral Oxygenation and Optic Nerve Sheath Diameter (MOD-TREND)

2. juni 2026 opdateret af: Neriman Doğan, Ankara Etlik City Hospital

Comparison of the Effects of Standard Trendelenburg and Modified Z Trendelenburg Positions on Cerebral Oxygenation (NIRS) and Optic Nerve Sheath Diameter in Laparoscopic Gynecological Cases

The purpose of this study is to compare the effects of the standard Trendelenburg position and the modified Z-Trendelenburg position on cerebral oxygenation and optic nerve sheath diameter (ONSD) in patients undergoing laparoscopic surgery. The prolonged use of the standard Trendelenburg position combined with pneumoperitoneum can increase intracranial pressure and affect cerebral blood flow. In this study, researchers will use non-invasive methods, including Near-Infrared Spectroscopy (NIRS) to monitor regional cerebral oxygenation, and ocular ultrasonography to measure ONSD as an indicator of intracranial pressure changes. The main goal is to determine whether the modified Z-Trendelenburg position serves as a safer physiological alternative by reducing these potential adverse effects compared to the standard position.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Laparoscopic surgeries frequently require patients to be placed in a steep Trendelenburg position with pneumoperitoneum to provide optimal surgical exposure. However, this combination induces significant physiological alterations, most notably an increase in intracranial pressure (ICP) and a potential compromise in cerebral venous drainage and regional cerebral oxygen saturation (rSO2). Non-invasive monitoring techniques, such as measuring the optic nerve sheath diameter (ONSD) via ultrasonography, provide reliable, real-time estimates of ICP changes. Additionally, Near-Infrared Spectroscopy (NIRS) allows for the continuous monitoring of cerebral oxygenation.

This prospective clinical study is designed to evaluate and compare the cerebral and hemodynamic impacts of the standard straight Trendelenburg position versus a modified Z-Trendelenburg position. Participants scheduled for elective laparoscopic procedures will be divided into specific positioning groups. Hemodynamic parameters, NIRS values, and ONSD measurements will be recorded at predefined time points throughout the surgery: at baseline, post-induction, after the establishment of pneumoperitoneum and positioning, at specific intervals during the surgery, and post-operatively in the recovery room. The primary hypothesis is that the modified Z-Trendelenburg position will attenuate the rise in ICP (reflected by a smaller increase in ONSD) and provide better cerebral oxygenation stability compared to the traditional standard position.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

70

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyrkiet (Türkiye)
    • Ankara
      • Ankara, Ankara, Tyrkiet (Türkiye), 06010
        • Ankara Etlik City 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

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

The study population consists of adult patients up to 80 years of age who [are admitted to the intensive care unit / are undergoing elective surgery / present to the emergency department]. The population excludes patients with known increased intracranial pressure, severe cerebrovascular, cardiovascular, or pulmonary diseases, morbid obesity (BMI > 35 kg/m^2), pregnancy, and any pre-existing ocular pathologies that could affect optic nerve sheath diameter (ONSD)

Beskrivelse

Inclusion Criteria:

Patients aged between 18 and 70 years

American Society of Anesthesiologists (ASA) physical status I or II

Scheduled for elective laparoscopic surgery requiring Trendelenburg position

Provided written informed consent

Exclusion Criteria:

Patient refusal to participate

History of severe cerebrovascular disease

Known increased intracranial pressure

Pre-existing ocular pathology that could affect optic nerve sheath diameter (ONSD) measurements (e.g., glaucoma, optic neuritis, ocular trauma)

Severe cardiovascular or pulmonary disease Body Mass Index (BMI) greater than 35 kg/m^2 Pregnancy

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Standard Trendelenburg Cohort
Patients undergoing elective laparoscopic surgery placed in the standard straight Trendelenburg position.
Procedure: Standard Trendelenburg Position
Placement of the patient in the traditional straight head-down tilt position required for laparoscopic surgical access and pneumoperitoneum
Modified Z-Trendelenburg Cohort
Patients undergoing elective laparoscopic surgery placed in the modified Z-Trendelenburg position (head-down tilt combined with leg flexion).
Procedure: Modified Z-Trendelenburg Position
Placement of the patient in a modified head-down tilt position combined with leg flexion

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Regional Cerebral Oxygen Saturation (rSO2)
Tidsramme: Baseline (before anesthesia induction), at 10, 45, 60, and 90 minutes after establishing pneumoperitoneum and surgical positioning, and 10 minutes after returning to the supine position.
Regional cerebral oxygen saturation (rSO2) will be measured bilaterally using Near-Infrared Spectroscopy (NIRS) sensors placed on the patient's forehead. This non-invasive monitoring will be used to evaluate cerebral oxygenation changes during different surgical positions and pneumoperitoneum. Values will be recorded as percentages (%).
Baseline (before anesthesia induction), at 10, 45, 60, and 90 minutes after establishing pneumoperitoneum and surgical positioning, and 10 minutes after returning to the supine position.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Mean Arterial Pressure (MAP)
Tidsramme: Baseline ( 10 minutes after anesthesia induction), at 10,45, 60, and 90 minutes after establishing pneumoperitoneum and surgical positioning, and 10 minutes after returning to the supine position.
Mean Arterial Pressure (MAP) will be continuously monitored and recorded to evaluate the cardiovascular effects of the pneumoperitoneum and modified positioning. Values will be reported in mmHg.
Baseline ( 10 minutes after anesthesia induction), at 10,45, 60, and 90 minutes after establishing pneumoperitoneum and surgical positioning, and 10 minutes after returning to the supine position.
Change in Optic Nerve Sheath Diameter (ONSD)
Tidsramme: Baseline ( 10 minutes after anesthesia induction), at 10, 45, 60, and 90 minutes after establishing pneumoperitoneum and surgical positioning, and 10 minutes after returning to the supine position.
Intracranial pressure changes will be evaluated indirectly by measuring the optic nerve sheath diameter (ONSD) using ocular ultrasonography. Measurements will be taken bilaterally and recorded in millimeters (mm).
Baseline ( 10 minutes after anesthesia induction), at 10, 45, 60, and 90 minutes after establishing pneumoperitoneum and surgical positioning, and 10 minutes after returning to the supine position.
Change in Peak Airway Pressure (Ppeak)
Tidsramme: Baseline (10 minutes after anesthesia induction), at 10,45, 60, and 90 minutes after establishing pneumoperitoneum and surgical positioning, and 10 minutes after returning to the supine posi
Peak airway pressure will be monitored continuously and recorded to evaluate the effects of pneumoperitoneum and different surgical positions on respiratory mechanics. Values will be reported in centimeters of water (cmH2O).
Baseline (10 minutes after anesthesia induction), at 10,45, 60, and 90 minutes after establishing pneumoperitoneum and surgical positioning, and 10 minutes after returning to the supine posi
Change in End-tidal Carbon Dioxide (EtCO2)
Tidsramme: Baseline (10 minutes after anesthesia induction), at 10, 45, 60, and 90 minutes after establishing pneumoperitoneum and surgical positioning, and 10 minutes after returning to the supine positi
End-tidal carbon dioxide levels will be monitored continuously via capnography to evaluate ventilation status during pneumoperitoneum and different positioning. Values will be reported in millimeters of mercury (mmHg).
Baseline (10 minutes after anesthesia induction), at 10, 45, 60, and 90 minutes after establishing pneumoperitoneum and surgical positioning, and 10 minutes after returning to the supine positi

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ankara Etlik City 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)

6. marts 2026

Primær færdiggørelse (Faktiske)

18. maj 2026

Studieafslutning (Faktiske)

18. maj 2026

Datoer for studieregistrering

Først indsendt

18. maj 2026

Først indsendt, der opfyldte QC-kriterier

2. juni 2026

Først opslået (Faktiske)

8. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AEŞH-EK-2026-048

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

The study population consists of adult female patients, aged 18 to 80 years, classified with an American Society of Anesthesiologists (ASA) physical status of I or II, who are scheduled to undergo elective laparoscopic gynecological surgery under general anesthesia at Ankara Etlik City Hospital. Eligible participants must have a Body Mass Index (BMI) between 18 and 30 kg/m2 and require the Trendelenburg position during surgery. Patients are excluded from the study population if they have a history of intracranial pathology, neurological disorders, severe ophthalmologic conditions (such as glaucoma), cerebrovascular diseases, severe cardiac or pulmonary diseases, profound anemia (Hb < 10 g/dL), or if they are pregnant.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Laparoskopisk gynækologisk kirurgi

Kliniske forsøg med Standard Trendelenburg Position

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Taiwan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner