RecruitingPhase 4NCT06874452

An Extension Test of Whether to Use Oral Anti-anxiety Drugs (Alprazolam) When Patients Choose Second Eye Cataract Surgery After Unblinding, and Analyze Their Anxiety, Satisfaction and Pain Satisfaction

Pain, Anxiety and Anesthetic Satisfaction for Patient With Different State Anxiety Underwent Cataract Surgery With Topical Anesthesia. An Extension Test of Whether to Use Oral Anti-anxiety Drugs (Alprazolam) When Patients Choose Second Eye Cataract Surgery After Unblinding, and Analyze Their Anxiety, Satisfaction and Pain Satisfaction.


Sponsor

National Taiwan University Hospital

Enrollment

250 participants

Start Date

Mar 25, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Phacoemulsification is one of the most used surgical methods for cataract surgery today, and the surgeries are under the anesthetic and sedative to make it comfortable and safe for patients. The most important issue is which method is the best for reducing the patient's anxiety, pain, and discomfort during surgery. Previous studies have analyzed the impact of intravenous injection of sedative on the quality of phacoemulsification surgery; however, the impact of oral anti-anxiety drugs (Alprazolam) on cataract surgery has not been intensively studied. Therefore, the purpose of this study is to investigate the impact of Alprazolam on satisfaction in cataract surgery. Oral sedation is more convenient and safer than intravenous sedation. Therefore, the investigators will further analyze whether patients using oral anti-anxiety drugs will have an improvement in the pain, anxiety, overall satisfaction, and side effects related to nausea and dizziness in the phacoemulsification surgery. This study will detailed record the patient's status in various aspects using questionnaire scales and scores. Through this research, the investigators will have the opportunity to comprehensively improve the surgical quality of cataract patients in a safe and convenient manner. The investigators plan to collect data from patients who participated in the study "Anxiety and surgery satisfaction for cataract patient with different state anxiety" (Research Ethics Committee Case No.: 202302067MINB) from October 2023 to August 2025, and plan to undergo phacoemulsification and intraocular lens implantation surgery in their second eye with local anesthetic at the Department of Ophthalmology, National Taiwan University Hospital. The sample size of 250 participants was determined based on the type of intervention, expected effect size, outcome variability, desired statistical significance, trial power, and experiences from similar studies. Vulnerable populations and those with any relevant contraindications will be excluded during the enrollment process. All medical records and surgical process data, including privacy-related information, will only be accessible to professional medical personnel for analysis. The focus of this study will be on intraoperative satisfaction, pain scores, relevant discomfort symptoms during the surgery, and postoperative anxiety assessment scales.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether taking a mild anti-anxiety medication (alprazolam, also known as Xanax) before cataract surgery on a second eye reduces anxiety, pain, and improves satisfaction — in people who previously chose not to take medication for their first eye surgery. **You may be eligible if...** - You are between 18 and 80 years old - You are planning to have cataract surgery on your second eye at the participating ophthalmology department - You previously participated in a related anxiety and cataract surgery study - You experienced pre-surgical anxiety (based on standard questionnaire scores) - You have no known side effects from alprazolam (Xanax) **You may NOT be eligible if...** - You have medical or medication contraindications that make surgery or alprazolam unsafe - You did not experience significant pre-surgical anxiety during your outpatient visit - You already regularly take anti-anxiety medications, sleeping pills, or pain medications - You are pregnant or breastfeeding - You have severe eye conditions (like corneal disease, advanced cataracts, or lens dislocation) that complicate standard surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAlprazolam (Xanax)

The patients will each receive a single tablet of 0.5mg Alprazolam 30 minutes before surgery. Patients older than 65 years or with liver disease will receive a reduced dose of 0.25 mg rather than 0.5 mg of oral Alprazolam 30 minutes before surgery.

OTHERPlacebo Tablets

The patients will each receive a single tablet of placebo 30 minutes before surgery.


Locations(1)

National Taiwan University Hospital

Taipei, Taiwan

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NCT06874452


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