Anxiety and Surgery Satisfaction for Cataract Patient With Different State Anxiety

Официальное название

Pain, Anxiety and Anesthetic Satisfaction for Patient With Different State Anxiety Underwent Cataract Surgery With Topical Anesthesia

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Xanax
  double-blind randomized controlled clinical trial: in a double-blind manner, to receive Xanax
• Другое placebo tablets
  double-blind randomized controlled clinical trial: in a double-blind manner, to receive a placebo (identical in appearance to Xanax but without any active effects)

Первичные конечные точки

• Beck Anxiety Inventory (BAI) [Срок оценки: 1-3 months]
• State-Trait Anxiety Inventory (STAI-S / STAI-T) [Срок оценки: 1-3 months]
• Cataract Surgery Records: Surgical Procedure [Срок оценки: 1 days]
• Cataract Surgery Records: Surgical Procedure (Intraoperative Monitoring) [Срок оценки: 1 days]
• Cataract Surgery Records: Surgical Procedure (Intraoperative Monitoring) [Срок оценки: 1 days]
• Cataract Surgery Records: Surgical Procedure (Intraoperative Monitoring) [Срок оценки: 1 days]
• Cataract Surgery Records: Pain Scale [Срок оценки: 1 days]
• Cataract Surgery Records: Anesthesia Satisfaction Rating Scale [Срок оценки: 1 days]
• Postoperative Follow-Up [Срок оценки: 1 days]
• Postoperative Follow-Up (Postoperative Symptoms) [Срок оценки: 1 days]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Тайвань · 1 центр

• National Taiwan University Hospital — Taipei

Идентификаторы

NCT: NCT06826417 · 202302067MINB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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