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 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

May 14, 2026

Status Verified

May 1, 2026

Enrollment Period

3 months

First QC Date

February 12, 2026

Last Update Submit

May 12, 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 to 30 minutes after spinal anesthesia and upper extremity positioning between the two study groups.

    Baseline and 30 minutes after spinal anesthesia and upper extremity positioning

Secondary Outcomes (2)

  • Change in Intraocular Pressure From Baseline to 15 Minutes

    Baseline and 15 minutes after spinal anesthesia and upper extremity positioning

  • Mean Arterial Pressure

    Baseline, 15 minutes, and 30 minutes after spinal anesthesia and upper extremity positioning

Study Arms (2)

Arms-at-Sides Position

EXPERIMENTAL

Participants underwent spinal anesthesia with both arms positioned alongside the body throughout the procedure.

Other: Upper Extremity Positioning

Hands-on-Chest Position

EXPERIMENTAL

Participants underwent spinal anesthesia with both hands positioned over the chest throughout the procedure.

Other: Upper Extremity Positioning

Interventions

Participants were assigned to one of two upper extremity positions during spinal anesthesia: arms positioned alongside the body or hands positioned over the chest.

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
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Due to the nature of the intervention, participants and care providers could not be blinded. However, intraocular pressure measurements were performed by an outcome assessor blinded to group allocation.
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

May 14, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations