Posizione dell'arto superiore e pressione intraoculare durante l'anestesia spinale (UEP-IOP)
Effetto della Posizione dell'Arto Superiore sulla Pressione Intraoculare Durante Anestesia Spinale nella Riparazione dell'Ernia Inguinale Aperta: Uno Studio Randomizzato Controllato
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.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Outside of the US
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Elâzığ, Outside of the US, Turchia (Türkiye), 23200
- Elazığ Fethi Sekin City Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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. |
|
Sperimentale: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Intraocular Pressure From Baseline to 30 Minutes
Lasso di tempo: 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)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Intraocular Pressure From Baseline to 15 Minutes
Lasso di tempo: 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
|
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Mean Arterial Pressure
Lasso di tempo: 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)
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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)
|
Collaboratori e investigatori
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- EFSH-ANES-IOP-RCT-2026
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