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

November 16, 2025 updated by: Zeliha Alicikus, Umraniye Education and Research Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Cataract stands as a significant cause of vision impairment worldwide, notably prevalent among the elderly. This study aims to explore the changes in intraocular pressure (IOP) and blood pressure under general anesthesia during cataract surgery in frail geriatric patients. The research emphasizes the critical role of frailty assessment in determining surgical risks among elderly surgical patients. It focuses on the hypothesis that frail individuals undergoing cataract surgery under general anesthesia might experience more pronounced effects on IOP and blood pressure during the surgical procedure compared to prefrail counterparts. This study emerges as a crucial step in understanding the impact of preoperative frailty assessment on surgical planning and outcomes.

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  • 65-85 age
  • ASA I-III
  • cataract surgery with genel anesthesia

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
group A
Frail scale:Non frail
Other: Intraocular pressure (IOP) was measured
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 B
Frail scale: Pre frail/frail
Other: Intraocular pressure (IOP) was measured
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intraocular pressure during genel anesthesia
Time Frame: through study completion, an average of 1 day
intraocular pressure (mmHg)
through study completion, an average of 1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hemodynamic data
Time Frame: through study completion, an average of 1 day
mean arterial pressure (mmHg)
through study completion, an average of 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umraniye Education and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2023

Primary Completion (Estimated)

January 30, 2026

Study Completion (Estimated)

February 27, 2026

Study Registration Dates

First Submitted

May 6, 2024

First Submitted That Met QC Criteria

June 25, 2024

First Posted (Actual)

July 1, 2024

Study Record Updates

Last Update Posted (Actual)

November 19, 2025

Last Update Submitted That Met QC Criteria

November 16, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UERH-AR-ZT-08

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cataract

Clinical Trials on Intraocular pressure (IOP) was measured

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Iran

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe