Clinical trial NCT06826417: Anxiety and Surgery Satisfaction for Cataract Patient With Different State Anxiety
Official title: Pain, Anxiety and Anesthetic Satisfaction for Patient With Different State Anxiety Underwent Cataract Surgery With Topical Anesthesia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oral Anxiolytic
Phacoemulsification
Cataract Surgery
Satisfaction Survey
State Anxiety
Keywords: Oral anxiolytic
Phacoemulsification
Cataract surgery
Satisfaction survey
State Anxiety
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Double-blind randomized controlled trial.
Primary purpose: OTHER

Brief summary: This study aims to explore the effects of anxiety traits on pain, anxiety, and anesthesia satisfaction in patients undergoing cataract surgery under topical anesthesia. On the day of recruitment, patients will complete the BAI, STAI-S, and STAI-T anxiety questionnaires to assess baseline anxiety levels. Thirty minutes before the surgery, patients will be randomly assigned, in a double-blind manner, to receive either Xanax or a placebo and will retake the BAI, STAI-S, and STAI-T questionnaires. After the surgery, patients' pain levels and anesthesia satisfaction will be evaluated, with the pain scale and satisfaction survey repeated the following day. The results will analyze the relationship between anxiety traits and pharmacological interventions on the surgical experience, aiming to optimize surgical procedures and improve overall patient comfort.

Detailed description: BACKGROUNDS Nowadays, phacoemulsification for cataract treatment is the most common surgical procedure performed and anesthetics procedure has been shifted from retrobulbar or peribulbar anesthesia to topical anesthesia (TA). Phacoemulsification under TA is proved to be a safe and low risk procedure with the incidence of adverse events requiring medical emergency team interventions to be 0.04%. However, it is not uncommon that patients can suffer from pain, anxiety and unpleasant visual sensation during this procedure. Complementary sedation has long been thought to alleviate the anxiety and pain of the patient during surgery with local anesthesia. Studies revealed that approximate one fourth of the patients underwent phacoemulsification under TA or retrobulbar anesthesia requested additional intravenous sedation of midazolam. However, the intravenous sedation, such as midazolam, propofol, or etomidate, increase the risk of additional anesthetic complications of heart rate, blood pressure, body temperature, and nausea, and therefore, anesthesia monitoring was mandatory during the surgery.

Compared with intravenous sedation, oral sedation is less costly and less invasive. Studies with different oral sedation agents revealed different effect. In the study of 41 patients serving themselves as control, patients reported more pain and photophobia in the surgery with TA alone than the other with midazolam syrup and oral transmucosal fentanyl citrate. However, two studies comparing oral diazepam or triazolam with intravenous midazolam showed similar rate of anxiety and pain or noninferior satisfaction. Moreover, the randomized control trial containing 50 procedures in each groups revealed that patients received TA alone during phacoemulsification reported similar pain or anxiety level to those received complementary intravenous midazolam.

Eligibility criteria: Inclusion Criteria:

1. Age between 18 and 80 years old.
2. Patients diagnosed with cataracts.
3. Scheduled for cataract surgery with phacoemulsification and intraocular lens implantation under surface anesthesia at National Taiwan University Hospital.
4. No adverse reactions to oral anti-anxiety medication (XANAX).

Exclusion Criteria:

1. Presence of any contraindications for surgery before the procedure.
2. Presence of any contraindications for medication before the procedure.
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).

Primary outcomes:
measure: Beck Anxiety Inventory (BAI)
timeFrame: 1-3 months
measure: State-Trait Anxiety Inventory (STAI-S / STAI-T)
timeFrame: 1-3 months
measure: Cataract Surgery Records: Surgical Procedure
timeFrame: 1 days
measure: Cataract Surgery Records: Surgical Procedure (Intraoperative Monitoring)
timeFrame: 1 days
measure: Cataract Surgery Records: Surgical Procedure (Intraoperative Monitoring)
timeFrame: 1 days
measure: Cataract Surgery Records: Surgical Procedure (Intraoperative Monitoring)
timeFrame: 1 days
measure: Cataract Surgery Records: Pain Scale
timeFrame: 1 days
measure: Cataract Surgery Records: Anesthesia Satisfaction Rating Scale
timeFrame: 1 days
measure: Postoperative Follow-Up
timeFrame: 1 days
measure: Postoperative Follow-Up (Postoperative Symptoms)
timeFrame: 1 days
measure: Postoperative Satisfaction Pain Scale
timeFrame: 1 days
measure: Postoperative Satisfaction Rating Scale
timeFrame: 1 days
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: