The Effect of Cranial Electro Therapy Stimulation in Reducing Perioperative Anxiety for Patients Undergoing First Eye Cataract Surgery
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Anxiety During Cataract Surgery Under Topical Anesthesia
研究概览
简要总结
Cranial electro stimulation (CES) provides safe, adequate, side-effect free sedation without excessive drowsiness in preoperative settings.
详细描述
CES Alpha-Stim is a non-invasive device which has been in place and has been approved for patients to reduce anxiety by the FDA. This study involves the use of CES Alpha-Stim device applied to the patient 30 minutes before and through-out cataract surgery procedure and then to measure the level of anxiety and discomfort by using a visual analog scale (VAS). We propose that by applying the device the patients will be able to have markedly less level of anxiety and discomfort before and during the surgery and will ultimately avoid the traditional use of sedative or analgesic drugs being used for these kinds of surgery.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both genders between 50 and 90 years old scheduled for an outpatient "first eye" cataract phacoemulsification with topical anesthesia.
- •ASA classification I II and III
排除标准
- •ASA classification IV (patients with a chronic or severe disease).
- •Hypersensitivity to midazolam or benzodiazepines
- •acute narrow-angle glaucoma
- •untreated open-angle glaucoma
- •Patients with any sort of psychiatric or neurological disorder
- •Patients on anti-anxiety medication
- •Patients who have demand-type pacemakers installed before 1999* *Note: These are the exclusions listed for liability purposes by Alpha-Stim. There are no FDA exclusions.
研究组 & 干预措施
Alpha-Stim intervention
One hour Alpha-Stim intervention with sham midazolam
干预措施: CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM (Device)
Sham Alpha-Stim with midazolam
Sham Alpha-Stim intervention with real midazolam administration
干预措施: MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY (Drug)
Placebo
No Alpha-Stim and only topical anesthetics
干预措施: NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED (Other)
结局指标
主要结局
Anxiety During Cataract Surgery Under Topical Anesthesia
时间窗: during the cataract surgery up to30 minutes
Anxiety was accessed via VAS from 0 to 10 with 10 being the most anxious.
次要结局
- Eye Discomfort Perception During Cataract Surgery Under Topical Anesthesia(during cataract surgery up to 30 minutes)
- Mean Arterial Pressure During the Cataract Surgery Under Topical Anesthesia(during cataract surgery up to 30 minutes)
- Heart Rate During Cataract Surgery Under Topical Anesthesia(during cataract surgery up to 30 minutes)