Preoperative EvaluationNCT06824935
Evaluation of Perioperative Anesthesia Requirements of Outpatient Cataract Patients
An observational study of Preoperative Evaluation and Outpatient, run by Naime Yalçın at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Preoperative Evaluation, Outpatient, Cataract Surgery Anesthesia
- What is being tested?
- Anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 470 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2025to 2 Jul 2025
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who will undergo local cataract surgery in the ophthalmology clinic by applying to our hospital's anesthesia polyclinic
Who may be able to join
- Being over 18 years old, ASA I-IV status, and undergoing cataract surgery under local-topical anesthesia
Who cannot join
- If the procedure is performed under general anesthesia or sedation, emergency surgery or ASA-E
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Sağlık Bilimleri Üniversitesi Kanuni Sultan Süleyman Eğitim ve Araştırma Hastanesi
Istanbul, 34000
About this study
Official title: Investigation of Perioperative Anesthesia Requirements of Outpatient Cataract Patients Who Underwent Preoperative Anesthesia Evaluation.
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.
Read the detailed description
Preoperative assessment is the first step in ensuring that patients receive safe anesthesia care. Over time, this process has changed significantly from an era when patients were admitted to the hospital the night before surgery to a time when the majority of patients, including those scheduled for major surgical procedures, arrive on the day of surgery. Outpatient preoperative assessment clinics are private and academic practices that require training in institutional staff; although common, the optimal model is unknown and may depend on the characteristics of the hospital, such as the specific types of care provided, geographic and socioeconomic differences in the population served by the hospital, patient expectations, and facility availability. The American Society of Anesthesiologists physical status (ASA-PS) classification provides a starting point for triage. Outpatient surgery may be safe even in patients with a high ASA-PS classification. A multicenter European study of 57,709 procedures including ASA PS III patients found that major complications such as stroke, myocardial infarction (MI), and pulmonary embolism were extremely rare and were not clearly associated with any deaths. Cataract surgery is the most frequently performed day surgery, with an estimated 3.3 million procedures performed annually by 2020 and 4.4 million by 2030. Almost all are performed in an outpatient setting with minimal intravenous sedation and different local anesthesia methods. The frequency of unplanned hospitalization on the day of surgery is estimated to be 0.05%. The majority of anesthesia interventions are related to the treatment of hypertension or bradycardia. Hypertension is often associated with anxiety and is often treated with sedation. Rarely, bradycardia requiring treatment typically occurs as a vagal response or following intravenous sedation. Considering the geriatric population and associated medical problems, monitored anesthesia care with anesthesia personnel may be considered more reliable in cataract surgery. Studies have reported that the rate of anesthesia call represents 3.4% of interventions, similar to those reported in the last 15 years, but some authors have reported higher anesthesia call rates of over 20%. In literature stated that the lack of premedication probably contributed to this increase, and that other factors such as the lack of anesthesia consultation, the level of information given to the patient, the definition of the criteria for calling the anesthesiologist, and the technique applied for topical anesthesia may have also affected the rates. The studies supported the need for anesthesia personnel to be present in the operating room to be evaluated by anesthesia personnel during cataract surgery by citing the study in 406 cases, in which the rate of anesthesia requirement during peribulbar anesthesia was shown as 28.5% and interventions were typically directed towards arrhythmia, agitation, or hypertension. The primary aim of this study was to evaluate patients who may need interventions in terms of anesthesia and reanimation among those who have completed preoperative anesthesia evaluations due to the possibility of consultation with the anesthesia department if needed in patients who will undergo cataract surgery under local-topical anesthesia. Investigator's secondary aim is to analyze the frequency of anesthesia interventions needed and the risk factors that play a role in these interventions by examining patient data, accompanied by patients' demographic data, medical history and preoperative anesthesia examinations.
- Being tested
- Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnesthesiaProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 8 weeks after registration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start2 Jan 2025
- Primary completion2 May 2025 (estimated)
- Study completion2 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative EvaluationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 470 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Naime Yalçın
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Naime Yalçın, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06824935
- Sponsor's protocol ID
- KAEK/2024.12.275
- Status last verified
- Feb 2025
- First submitted
- 29 Jan 2025
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Perioperative Anesthesia Requirements of Outpatient Cataract Patients Who Underwent Preoperative Anesthesia Evaluation.
- ClinicalTrials.gov ID
- NCT06824935
- Acronym / sponsor ID
- KAEK/2024.12.275
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 470 participants (estimated)
- Lead sponsor
- Naime YalçınUniversity, hospital or other
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- 2 May 2025 (estimated)
- Study completion
- 2 Jul 2025 (estimated)
- First posted
- 13 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Preoperative assessment is the first step in ensuring that patients receive safe anesthesia care. Over time, this process has changed significantly from an era when patients were admitted to the hospital the night before surgery to a time when the majority of patients, including those scheduled for major surgical procedures, arrive on the day of surgery. Outpatient preoperative assessment clinics are private and academic practices that require training in institutional staff; although common, the optimal model is unknown and may depend on the characteristics of the hospital, such as the specific types of care provided, geographic and socioeconomic differences in the population served by the hospital, patient expectations, and facility availability. The American Society of Anesthesiologists physical status (ASA-PS) classification provides a starting point for triage. Outpatient surgery may be safe even in patients with a high ASA-PS classification. A multicenter European study of 57,709 procedures including ASA PS III patients found that major complications such as stroke, myocardial infarction (MI), and pulmonary embolism were extremely rare and were not clearly associated with any deaths. Cataract surgery is the most frequently performed day surgery, with an estimated 3.3 million procedures performed annually by 2020 and 4.4 million by 2030. Almost all are performed in an outpatient setting with minimal intravenous sedation and different local anesthesia methods. The frequency of unplanned hospitalization on the day of surgery is estimated to be 0.05%. The majority of anesthesia interventions are related to the treatment of hypertension or bradycardia. Hypertension is often associated with anxiety and is often treated with sedation. Rarely, bradycardia requiring treatment typically occurs as a vagal response or following intravenous sedation. Considering the geriatric population and associated medical problems, monitored anesthesia care with anesthesia personnel may be considered more reliable in cataract surgery. Studies have reported that the rate of anesthesia call represents 3.4% of interventions, similar to those reported in the last 15 years, but some authors have reported higher anesthesia call rates of over 20%. In literature stated that the lack of premedication probably contributed to this increase, and that other factors such as the lack of anesthesia consultation, the level of information given to the patient, the definition of the criteria for calling the anesthesiologist, and the technique applied for topical anesthesia may have also affected the rates. The studies supported the need for anesthesia personnel to be present in the operating room to be evaluated by anesthesia personnel during cataract surgery by citing the study in 406 cases, in which the rate of anesthesia requirement during peribulbar anesthesia was shown as 28.5% and interventions were typically directed towards arrhythmia, agitation, or hypertension. The primary aim of this study was to evaluate patients who may need interventions in terms of anesthesia and reanimation among those who have completed preoperative anesthesia evaluations due to the possibility of consultation with the anesthesia department if needed in patients who will undergo cataract surgery under local-topical anesthesia. Investigator's secondary aim is to analyze the frequency of anesthesia interventions needed and the risk factors that play a role in these interventions by examining patient data, accompanied by patients' demographic data, medical history and preoperative anesthesia examinations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will undergo local cataract surgery in the ophthalmology clinic by applying to our hospital's anesthesia polyclinic
Key inclusion criteria (1 listed)
- Being over 18 years old, ASA I-IV status, and undergoing cataract surgery under local-topical anesthesia
Key exclusion criteria (1 listed)
- If the procedure is performed under general anesthesia or sedation, emergency surgery or ASA-E
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AnesthesiaThe 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. | Procedure or surgery | – |
Primary outcome
Number and nature of anesthesia requirements in local cataract surgery
Time frame: Up to 8 weeks after registration
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preoperative Evaluation and Outpatient, run by Naime Yalçın at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and nature of anesthesia requirements in local cataract surgery (time frame: Up to 8 weeks after registration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.