NCT06824935

Brief Summary

According to the literature, preoperative evaluation has been shown in studies to be the first step in ensuring that patients' anesthesia care is carried out safely. In cataract surgery, which is a day anesthesia procedure frequently observed in the geriatric population, topical-local anesthesia is mostly applied. It is believed that preoperative anesthesia evaluation will be beneficial due to the complications that may develop during the procedure, patient safety and therefore the duration of postoperative hospital stay. The aim of the study is to evaluate patients who may need anesthesia intervention among patients whose preoperative anesthesia evaluations have been completed due to the possibility of consultation from the anesthesia department if necessary for patients who will undergo cataract surgery with local-topical anesthesia.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
470

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

January 2, 2025

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 13, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2025

Completed
Last Updated

February 13, 2025

Status Verified

February 1, 2025

Enrollment Period

4 months

First QC Date

January 29, 2025

Last Update Submit

February 7, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number and nature of anesthesia requirements in local cataract surgery

    Patients will be examined with parameters such as age, gender, weight and height will be combined to report BMI in kg/m\^2, history of chronic disease, history of medication, smoking, alcohol, allergy, previous eye surgery, ASA, type of surgical anesthesia, reasons for anesthesia requirement, increasing oxygen flow rate, clarifying ECG, opening i.v. access, sedation, general anesthesia, additional medication, and length of hospital stay.

    Up to 8 weeks after registration

Interventions

AnesthesiaPROCEDURE

The study planned to investigate the anesthesia requirements and frequency and the risk factors that play a role in the anesthesia of patients who had completed preoperative anesthesia evaluation and were going to undergo outpatient cataract surgery.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who will undergo local cataract surgery in the ophthalmology clinic by applying to our hospital's anesthesia polyclinic

You may qualify if:

  • Being over 18 years old, ASA I-IV status, and undergoing cataract surgery under local-topical anesthesia

You may not qualify if:

  • If the procedure is performed under general anesthesia or sedation, emergency surgery or ASA-E

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sağlık Bilimleri Üniversitesi Kanuni Sultan Süleyman Eğitim ve Araştırma Hastanesi

Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Anesthesia

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Specialist Anesthesiology and Reanimation, Principal Investigator

Study Record Dates

First Submitted

January 29, 2025

First Posted

February 13, 2025

Study Start

January 2, 2025

Primary Completion

May 2, 2025

Study Completion

July 2, 2025

Last Updated

February 13, 2025

Record last verified: 2025-02

Locations