Pozycja górnej kończyny a ciśnienie wewnątrzgałkowe podczas znieczulenia podpajęczynówkowego (UEP-IOP)
Wpływ pozycji kończyny górnej na ciśnienie wewnątrzgałkowe podczas znieczulenia podpajęczynówkowego w otwartej operacji przepukliny pachwinowej: badanie randomizowane z grupą kontrolną
This prospective randomized controlled trial evaluated the effect of two upper extremity positions on intraocular pressure (IOP) in adult patients undergoing surgery under spinal anesthesia. Participants were randomly assigned to either an arms-at-sides position or a hands-on-chest position. IOP was measured in the right eye using an Icare ic200 rebound tonometer at predefined perioperative time points. Hemodynamic parameters, including mean arterial pressure, heart rate, and oxygen saturation, were also recorded. The primary outcome was the change in IOP from baseline to 30 minutes after application of the assigned upper extremity position between the two upper extremity position groups.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
Intraocular pressure (IOP) may be influenced by systemic hemodynamics, venous return, episcleral venous pressure, and patient positioning. Although the effects of head and body position on IOP have been investigated, the impact of upper extremity positioning during spinal anesthesia has not been clearly established. This prospective randomized controlled trial was conducted at Elazig Fethi Sekin City Hospital. Adult patients scheduled for elective surgery under spinal anesthesia were enrolled. After written informed consent, participants were randomly assigned to one of two upper extremity positions: arms positioned alongside the body or hands positioned on the chest. IOP was measured in the right eye using an Icare ic200 rebound tonometer. Measurements were obtained at baseline before spinal anesthesia, 15 minutes after spinal anesthesia immediately before application of the assigned upper extremity position, and 30 minutes after application of the assigned position (approximately 45 minutes after spinal anesthesia). Head and neck position was maintained neutral throughout the measurement period. Hemodynamic parameters, including mean arterial pressure, heart rate, and peripheral oxygen saturation, were recorded simultaneously. The primary outcome was the between-group comparison of the change in IOP from baseline to 30 minutes after application of the assigned upper extremity position. Secondary outcomes included IOP change at 15 minutes and perioperative hemodynamic changes.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
Outside of the US
-
Elâzığ, Outside of the US, Turcja (Türkiye), 23200
- Elazığ Fethi Sekin City Hospital
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Age between 18 and 80 years
- ASA physical status I-III
- Scheduled for elective open inguinal hernia repair under spinal anesthesia
- Ability to undergo intraocular pressure measurement
- Provision of written informed consent
Exclusion Criteria:
- History of glaucoma or ocular hypertension
- Previous ocular surgery or ocular trauma
- Active ocular disease or infection
- Contraindication to spinal anesthesia
- Inability to cooperate with intraocular pressure measurements
- Refusal to participate
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Podstawowa nauka
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Arms-at-Sides Position
Participants underwent spinal anesthesia. After the T15 intraocular pressure measurement, both arms were positioned alongside the body, parallel to the torso, with the palms facing upward, and this position was maintained for approximately 30 minutes until the final T45 measurement. |
Participants were assigned to one of two upper extremity positions after the T15 intraocular pressure measurement: arms positioned alongside the body or hands positioned over the chest. The assigned position was maintained for approximately 30 minutes until the final T45 intraocular pressure measurement. |
|
Eksperymentalny: Hands-on-Chest Position
Participants underwent spinal anesthesia. After the T15 intraocular pressure measurement, both upper extremities were adducted with the elbows flexed, and the open hands were placed one over the other on the anterior chest wall. This position was maintained for approximately 30 minutes until the final T45 measurement. |
Participants were assigned to one of two upper extremity positions after the T15 intraocular pressure measurement: arms positioned alongside the body or hands positioned over the chest. The assigned position was maintained for approximately 30 minutes until the final T45 intraocular pressure measurement. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Intraocular Pressure From Baseline to 30 Minutes
Ramy czasowe: Baseline before spinal anesthesia and 30 minutes after application of the assigned upper extremity position (approximately 45 minutes after spinal anesthesia)
|
Intraocular pressure was measured in the right eye using an Icare ic200 rebound tonometer. The primary outcome was the change in intraocular pressure from baseline before spinal anesthesia to 30 minutes after application of the assigned upper extremity position between the two study groups. |
Baseline before spinal anesthesia and 30 minutes after application of the assigned upper extremity position (approximately 45 minutes after spinal anesthesia)
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Intraocular Pressure From Baseline to 15 Minutes
Ramy czasowe: Baseline before spinal anesthesia and 15 minutes after spinal anesthesia, immediately before application of the assigned upper extremity position
|
Intraocular pressure was measured in the right eye using an Icare ic200 rebound tonometer. This secondary outcome was the change in intraocular pressure from baseline to 15 minutes after spinal anesthesia, immediately before application of the assigned upper extremity position, between the two study groups. |
Baseline before spinal anesthesia and 15 minutes after spinal anesthesia, immediately before application of the assigned upper extremity position
|
|
Mean Arterial Pressure
Ramy czasowe: Baseline before spinal anesthesia, 15 minutes after spinal anesthesia immediately before positioning, and 30 minutes after application of the assigned upper extremity position (approximately 45 minutes after spinal anesthesia)
|
Mean arterial pressure was recorded simultaneously with the intraocular pressure measurements and evaluated between the two study groups. |
Baseline before spinal anesthesia, 15 minutes after spinal anesthesia immediately before positioning, and 30 minutes after application of the assigned upper extremity position (approximately 45 minutes after spinal anesthesia)
|
Współpracownicy i badacze
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- EFSH-ANES-IOP-RCT-2026
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .