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

NCT ID: NCT06482996

Last Updated: 2025-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-20

Study Completion Date

2026-02-27

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cataract

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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group A

Frail scale:Non frail

Intraocular pressure (IOP) was measured

Intervention Type 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 B

Frail scale: Pre frail/frail

Intraocular pressure (IOP) was measured

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Umraniye Education and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Zeliha Alicikus

head of Anesthesia and reanimation

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Umraniye Education and Research hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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zeliha tuncel

Role: CONTACT

05053577483

Facility Contacts

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Zeliha Tuncel

Role: primary

0216 632 18 18

Duygu Harika Ozer

Role: backup

0216 632 18 18

Other Identifiers

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UERH-AR-ZT-08

Identifier Type: -

Identifier Source: org_study_id

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