Clinical Outcomes of Sedation in Cataract Surgery Performed Under Topical Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Patient satisfaction after cataract surgery
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Participants and the operating surgeon will be blinded to group allocation. Study medications, including placebo saline in the non-sedation group, will be prepared in identical syringes by an independent clinician not involved in patient care or outcome assessment. Sedative agents will be administered in equal volumes to maintain blinding. Postoperative outcomes, including patient satisfaction, will be evaluated by a blinded outcome assessor.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Topical anesthesia only (placebo)
Patients will receive topical anesthesia for cataract surgery. An intravenous placebo (normal saline) will be administered in an identical volume to maintain blinding. No sedative or opioid medication will be given.
干预措施: Normal Saline (Drug)
Topical anesthesia + midazolam
Patients will receive topical anesthesia combined with intravenous midazolam administered for sedation during cataract surgery. The medication will be prepared and administered in a standardized dose and volume to maintain blinding.
干预措施: Midalozam (Drug)
Topical anesthesia + midazolam + fentanyl
Patients will receive topical anesthesia combined with intravenous midazolam and fentanyl for sedation during cataract surgery. Medications will be administered in standardized doses and equal volumes to ensure blinding across study groups.
干预措施: Midalozam (Drug)
Topical anesthesia + midazolam + fentanyl
Patients will receive topical anesthesia combined with intravenous midazolam and fentanyl for sedation during cataract surgery. Medications will be administered in standardized doses and equal volumes to ensure blinding across study groups.
干预措施: Fentanyl (IV) (Drug)
结局指标
主要结局
Patient satisfaction after cataract surgery
时间窗: 1 hour postoperatively
Patient satisfaction will be assessed using the validated Turkish version of the Iowa Satisfaction with Anesthesia Scale (ISAS-T). The ISAS-T total score will be calculated according to the instrument instructions; higher scores indicate greater satisfaction.
次要结局
- Intraoperative sedation level(During surgery (intraoperative period)
- Preoperative anxiety level(Preoperative period (before surgery))
- Surgeon satisfaction(Immediately after surgery)
- İntraoperative heart rate(During surgery)
- İntraoperative mean arterial pressure(During surgery)
- Respiratory events(During surgery)
研究者
Bekzat Emilbekov
Research Assistant in Anesthesiology
Istanbul University - Cerrahpasa