Upper Extremity Position and Intraocular Pressure During Spinal Anesthesia: A Randomized Controlled Trial (UEP-IOP)
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Outside of the US
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Elâzığ, Outside of the US, Turkey (Türkiye), 23200
- Elazığ Fethi Sekin City Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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. |
|
Experimental: 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Intraocular Pressure From Baseline to 30 Minutes
Time Frame: 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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Intraocular Pressure From Baseline to 15 Minutes
Time Frame: 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
Time Frame: 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)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- EFSH-ANES-IOP-RCT-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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