NCT07424417

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2026

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 20, 2026

Completed
Last Updated

September 30, 2026

Status Verified

September 1, 2026

Enrollment Period

3 months

First QC Date

February 12, 2026

Last Update Submit

September 25, 2026

Conditions

Keywords

Upper Extremity PositionIntraocular PressureSpinal AnesthesiaSurgical Positioning

Outcome Measures

Primary Outcomes (1)

  • Change in Intraocular Pressure From Baseline to 30 Minutes

    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 Outcomes (2)

  • Change in Intraocular Pressure From Baseline to 15 Minutes

    Baseline before spinal anesthesia and 15 minutes after spinal anesthesia, immediately before application of the assigned upper extremity position

  • Mean Arterial Pressure

    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)

Study Arms (2)

Arms-at-Sides Position

EXPERIMENTAL

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.

Other: Upper Extremity Positioning

Hands-on-Chest Position

EXPERIMENTAL

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.

Other: Upper Extremity Positioning

Interventions

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.

Arms-at-Sides PositionHands-on-Chest Position

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elazığ Fethi Sekin City Hospital

Elâzığ, Outside of the US, 23200, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Due to the visible nature of the upper extremity positioning intervention, blinding of participants, care providers, and the outcome assessor was not feasible. The investigator performing intraocular pressure measurements was not involved in randomization sequence generation or group assignment, and measurements were standardized using the same device, prespecified eye, neutral head and neck position, and predefined measurement quality criteria.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2026

First Posted

February 20, 2026

Study Start

November 20, 2025

Primary Completion

February 10, 2026

Study Completion

February 10, 2026

Last Updated

September 30, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations