Clinical Outcomes of Sedation in Cataract Surgery Performed Under Topical Anesthesia

Обзор

This study aims to evaluate the clinical outcomes of different sedation strategies in patients undergoing cataract surgery performed under topical anesthesia. Cataract surgery is commonly performed under topical anesthesia; however, some patients may experience anxiety, discomfort, or inadequate cooperation during the procedure. Sedation may improve patient comfort and surgical conditions, but it may also be associated with potential adverse effects. In this randomized, prospective study, patients will be assigned to one of three groups: topical anesthesia alone, topical anesthesia combined with midazolam, or topical anesthesia combined with midazolam and fentanyl. Intraoperative sedation levels, hemodynamic parameters, patient satisfaction, and surgeon satisfaction will be assessed and compared among the groups. The results of this study are expected to provide evidence regarding the effectiveness and safety of sedation during cataract surgery performed under topical anesthesia and to help optimize perioperative sedation strategies for these patients.

Подробное описание

Cataract surgery is one of the most frequently performed ophthalmologic procedures and is commonly carried out under topical anesthesia. Although topical anesthesia provides adequate analgesia, some patients may experience anxiety, discomfort, or difficulty in maintaining cooperation during the procedure. Sedation is frequently used as an adjunct to topical anesthesia to improve patient comfort and surgical conditions; however, concerns remain regarding potential respiratory and hemodynamic adverse effects, particularly in elderly patients.

This prospective, randomized clinical study is designed to evaluate the clinical outcomes of different sedation strategies in patients undergoing cataract surgery performed under topical anesthesia. Adult patients scheduled for elective cataract surgery will be randomly assigned to one of three groups. Group 1 will receive topical anesthesia alone without sedation. Group 2 will receive topical anesthesia combined with intravenous midazolam. Group 3 will receive topical anesthesia combined with intravenous midazolam and fentanyl. Randomization will be performed using a predefined allocation method to ensure balanced group distribution.

All patients will be monitored using standard intraoperative monitoring, including non-invasive blood pressure, electrocardiography, and peripheral oxygen saturation. Supplemental oxygen will be administered when clinically indicated. Sedative agents will be administered according to standardized dosing protocols. Intraoperative sedation depth will be assessed using a validated sedation scale, and hemodynamic and respiratory parameters will be recorded throughout the procedure.

The primary outcome of the study is postoperative patient satisfaction, which will be assessed using the Iowa Satisfaction with Anesthesia Scale - Turkish version (ISAS-T). Secondary outcomes include intraoperative sedation level, surgeon satisfaction, hemodynamic stability, respiratory events, additional sedative requirements, and the occurrence of sedation-related adverse effects. Surgeon satisfaction will be evaluated using a standardized Likert-type scale.

The results of this study are expected to provide evidence regarding the impact of different sedation strategies on patient satisfaction and overall clinical outcomes in cataract surgery performed under topical anesthesia. These findings may contribute to optimizing perioperative sedation practices and improving patient-centered care in ophthalmic anesthesia.

Вмешательства

• Препарат Normal Saline
  Intravenous normal saline administered in an identical volume as placebo to maintain blinding. No sedative or opioid medication will be given.
• Препарат Midalozam
  Intravenous midazolam administered for procedural sedation during cataract surgery performed under topical anesthesia. The medication will be prepared and administered in standardized doses and identical volumes to maintain blinding.
• Препарат Fentanyl (IV)
  intravenous fentanyl administered in combination with midazolam to provide analgesia and sedation during cataract surgery under topical anesthesia. The medication will be prepared and administered in standardized doses and equal volumes to ensure blinding across study groups.

Первичные конечные точки

• Patient satisfaction after cataract surgery [Срок оценки: 1 hour postoperatively]

Вторичные конечные точки (6)

• Intraoperative sedation level [Срок оценки: During surgery (intraoperative period]
• Preoperative anxiety level [Срок оценки: Preoperative period (before surgery)]
• Surgeon satisfaction [Срок оценки: Immediately after surgery]
• İntraoperative heart rate [Срок оценки: During surgery]
• İntraoperative mean arterial pressure [Срок оценки: During surgery]
• Respiratory events [Срок оценки: During surgery]

Критерии участия

Критерии включения

• Age ≥ 50 years
• American Society of Anesthesiologists (ASA) physical status I-III
• Patients scheduled for elective unilateral cataract surgery
• Surgery planned to be performed under topical anesthesia
• Ability to understand the study procedures and provide written informed consent after being fully informed about the study

Критерии исключения

• Refusal to participate in the study or withdrawal of consent at any stage of the study
• Known intolerance or contraindication to sedative and/or opioid medications
• Presence of significant cardiac arrhythmias
• Severe chronic obstructive pulmonary disease (COPD)
• Hepatic or renal failure
• Inability to cooperate due to cognitive impairment or hearing disability
• Opioid dependence
• Diagnosis of obstructive sleep apnea syndrome (OSAS)
• New York Heart Association (NYHA) class III-IV heart failure
• Conversion to general anesthesia for any reason during surgery

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine — Istanbul

Публикации

• Dexter F, Aker J, Wright WA. Development of a measure of patient satisfaction with monitored anesthesia care: the Iowa Satisfaction with Anesthesia Scale. Anesthesiology. 1997 Oct;87(4):865-73. doi: 10.1097/00000542-199710000-00021. PMID 9357889

Идентификаторы

NCT: NCT07347886 · 1503993

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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