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

NCT06874452 | Recruiting Phase 4

• 1 other identifier: 202410134MINC
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ophthalmology; Cataract Surgery Anesthesia; Oral Anxiolytic; Satisfaction Survey

Keywords

oral anti-anxiety drugs; oral anxiolytic; ophthalmology; cataract surgery anesthesia; satisfaction survey

Outcome Measures

Primary Outcomes (1)

• 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.

  1 day

Secondary Outcomes (2)

• The change of preoperative and postoperative anxiety level

  1 day

• Level of postoperative pain

  1 day

Study Arms (2)

Xanax

EXPERIMENTAL

0.5mg XANAX or 0.25MG XANAX for patients older than 65 years or with liver disease.

Drug: Alprazolam (Xanax)

placebo

PLACEBO COMPARATOR

The placebo tablet is visually identical to the experiment group.

Other: Placebo Tablets

Interventions

Placebo Tablets OTHER

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

placebo

Alprazolam (Xanax) DRUG

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.

Xanax

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Pregnancy or breastfeeding during the preoperative period.
• Severe corneal diseases, overripe cataracts, small pupils, or lens dislocation leading to difficulties in conventional surgery.
• Patients under surface anesthesia who cannot fully cooperate with the surgical procedure.
• Pregnant or uncertain pregnancy status (women under 55 years old to be verbally asked by research team members).

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Interventions

Alprazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Chiun Ho Hou, Ph.D

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chiun Ho Hou, Ph.D

CONTACT

+88623123456; chiunhohou@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: open label, double-arm study

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 13, 2025
• Study Start: March 25, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)