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.
Age between 18 and 80 years old.
Enrolled in "Anxiety and surgery satisfaction for cataract patient with different state anxiety" (Research Ethics Committee Case No.: 202302067MINB).
Plan to undergo phacoemulsification and intraocular lens implantation surgery with topical anesthetic on the second eye at the Department of Ophthalmology.
Subject who does not have side effect from XANAX.
Presence of any surgery contraindications.
Presence of any medication contraindications.
Inability to provide clear and complete answers to relevant questionnaires, or expression of no preoperative anxiety during the outpatient visit, or scores below 21 on the STAI-S or STAI-T assessment.
Regular use of anti-anxiety medications, sleeping pills, or analgesics before the procedure.
Parallel
Alprazolam (Xanax)
DrugThe 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.
Placebo Tablets
Other interventionThe patients will each receive a single tablet of placebo 30 minutes before surgery.
Anesthesia Satisfaction Assessment
The anesthesia satisfaction rating scale evaluates patients' satisfaction with the anesthesia experience during surgical procedures, focusing on factors such as pain management, comfort, and communication with the anesthesia team. The scales typically use a numerical rating system, such as a 10-point scale, where higher scores indicate greater satisfaction.
The change of preoperative and postoperative anxiety level
The change of preoperative and postoperative anxiety level is evaluation with State-Trait Anxiety Inventory (STAI) and Beck Anxiety Inventory (BAI). STAI is focus on state anxiety (SA) and trait anxiety (TA). The inventory comprises 40 items, with 20 items assessing state anxiety and 20 items assessing trait anxiety. Each item is rated on a 4-point scale (1 to 4), resulting in a total score range of 20 to 80 for both SA and TA. Higher scores indicate more severe anxiety. BAI consists of 21 items covering physiological and cognitive anxiety symptoms, such as palpitations, breathlessness, and tension. Each item is rated on a 4-point scale (0 to 3) based on the frequency or severity of symptoms, with a total score range of 0 to 63. Higher scores indicate more severe anxiety.
Level of postoperative pain
The immediate postoperative pain levels is documented to assess the patient's postoperative satisfaction. The pain level is rated on a 10-point scale (0 to 10). 0 point represents no pain, 1-2 points represent mild pain, 3-4 points represent moderate pain, 5-6 points represent severe pain, 7-8 points represent very severe pain, and 9-10 points represent worst possible pain.
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