General Anesthesia on Blood Pressure and Intraocular Pressure in Geriatric Patients Undergoing Cataract Surgery

NCT06482996 | Recruiting

• 1 other identifier: UERH-AR-ZT-08
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of the study is to investigate the correlation between preoperative hemodynamics and frailty scores in patients undergoing cataract surgery under general anesthesia. The secondary objective is to explore the relationship between preoperative and postoperative intraocular pressure changes and frailty scores.

Conditions

Cataract

Keywords

Cataract surgery; Frailty

Outcome Measures

Primary Outcomes (1)

• intraocular pressure during genel anesthesia

  intraocular pressure (mmHg)

  through study completion, an average of 1 day

Secondary Outcomes (1)

• hemodynamic data

  through study completion, an average of 1 day

Study Arms (2)

group A

Frail scale:Non frail

Other: Intraocular pressure (IOP) was measured

group B

Frail scale: Pre frail/frail

Other: Intraocular pressure (IOP) was measured

Interventions

Intraocular pressure (IOP) was measured OTHER

The Frail Scale was used to assess the frailty of the patients.Intraocular pressure (IOP) was measured before anesthesia, 5 minutes after induction of anesthesia and 1 hour postoperatively. IOP was measured using a Tono-pen tonometer (AccuPen). The normal range of IOP is 11-21 mmHg (mean 16 mmHg) and values above 24 mmHg are pathologic.

group A; group B

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This prospective randomized controlled double-blind study included a total of 80 ASA I-III patients aged 65-85 years undergoing cataract surgery under general anesthesia. Randomization Patients were randomly divided into two groups with frailty score as non-frail (40 patients) and pre-frail/frail (40 patients) by closed envelope method.

You may qualify if:

• age
• ASA I-III
• cataract surgery with genel anesthesia

You may not qualify if:

• cerebrovascular disease,
• mental retardation and psychiatric illness,
• pulmonary infection, history of advanced COPD or respiratory failure,
• EF less than 40%, presence of cardiovascular disease,
• bleeding diathesis,
• renal and hepatic insufficiency,
• presence of diabetes mellitus, diuretic/mannitol users,
• substance abuse
• BMI \>30

Sponsors & Collaborators

• Umraniye Education and Research Hospital: lead

Study Sites (1)

Umraniye Education and Research hospital

Istanbul, 34764, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Cataract; Frailty

Interventions

Intraocular Pressure

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ocular Physiological Phenomena

Central Study Contacts

zeliha tuncel

CONTACT

05053577483; zelihalara@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of Anesthesia and reanimation

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: July 1, 2024
• Study Start: October 20, 2023
• Primary Completion: January 30, 2026
• Study Completion: February 27, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

TU (1)