Spinal Anesthesia - Intraocular Pressure

Intraocular Pressure Clinical Trial

Official title:

Intraocular Pressure Changes After Spinal Anesthesia: Acute and Subacute Effects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02061644
• Other study ID #: Spinal-IOP
• Status: Completed
• Phase: N/A
• First received: February 10, 2014
• Last updated: April 4, 2014
• Start date: March 2014
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• Source: Adiyaman University Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Drug and Medical Device Institution
• Study type: Interventional

Clinical Trial Summary

We aim to investigate the effect of spinal anesthesia on intraocular pressure.

Description:

Spinal anesthesia provides adequate anesthetic conditions for many operations. These operations include orthopedic, urological, gynecological and many general surgery operations. Although few, side effects of the procedure and its effects on body are well known. However, there is inadequate knowledge about the effects of spinal anesthesia on pressure changes in the eyes. These pressure changes in eyes can result in some detriments. Elevated pressures in the eyes can result in disease known as glaucoma, that makes hazard to eyes. Decreased eye pressures can also result in some eye detriments.

We aimed to investigate the effects of spinal anesthesia procedure on eye (intraocular) pressure changes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• patients having general surgery operations under umbilicus

• patients of American Society of Anesthesiologists (ASA) status I-II

Exclusion Criteria:

• patients denying spinal anesthesia

• contraindications for spinal anesthesia

• eye diseases

• hypertension

• ASA status III or more

Study Design

Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Intraocular Pressure

Intervention

Other:
• Spinal anesthesia
Routine spinal anesthesia procedure will be made to the patients for surgical anesthesia.

Locations

Country	Name	City	State
Turkey	Adiyaman University Research Hospital	Adiyaman

Sponsors (1)

Lead Sponsor	Collaborator
Adiyaman University Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of the patients with changed intraocular pressure		One month	No