Using oral anti-anxiety medication during second eye cataract surgery
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.
This study is testing if taking the anti-anxiety medication XANAX can help people feel less anxious and more comfortable during their second eye cataract surgery compared to a placebo.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Taipei) |
| Trial ID | NCT06874452 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of the oral anti-anxiety drug XANAX on patient satisfaction, anxiety, and pain during phacoemulsification cataract surgery. It aims to determine whether oral sedation can provide a safer and more convenient alternative to intravenous sedation, which is commonly used but carries additional risks. Patients undergoing surgery on their second eye will be monitored for their anxiety levels, pain experiences, and overall satisfaction with the procedure. The study will compare outcomes between those receiving XANAX and those receiving a placebo.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 who are scheduled for cataract surgery on their second eye and do not have contraindications to XANAX.
Not a fit: Patients with severe corneal diseases, contraindications to surgery, or those who do not experience preoperative anxiety may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved patient comfort and satisfaction during cataract surgery.
How similar studies have performed: Previous studies have shown varying success with oral sedation in surgical settings, but the specific use of XANAX in cataract surgery is less explored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age between 18 and 80 years old. 2. Enrolled in "Anxiety and surgery satisfaction for cataract patient with different state anxiety" (Research Ethics Committee Case No.: 202302067MINB). 3. Plan to undergo phacoemulsification and intraocular lens implantation surgery with topical anesthetic on the second eye at the Department of Ophthalmology. 4. Subject who does not have side effect from XANAX. Exclusion Criteria: 1. Presence of any surgery contraindications. 2. Presence of any medication contraindications. 3. 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. 4. Regular use of anti-anxiety medications, sleeping pills, or analgesics before the procedure. 5. Pregnancy or breastfeeding during the preoperative period. 6. Severe corneal diseases, overripe cataracts, small pupils, or lens dislocation leading to difficulties in conventional surgery. 7. Patients under surface anesthesia who cannot fully cooperate with the surgical procedure. 8. Pregnant or uncertain pregnancy status (women under 55 years old to be verbally asked by research team members).
Where this trial is running
Taipei
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Principal investigator: Chiun Ho Hou, Ph.D — National Taiwan University Hospital
- Study coordinator: Chiun Ho Hou, Ph.D
- Email: chiunhohou@gmail.com
- Phone: +88623123456
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.