The Comparison of Dexmedetomidine and Remifentanil Infusion in Geriatric Patients Undergoing Outpatient Cataract Surgery: A Prospective, Randomized, Blinded Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Sedation level
研究概览
简要总结
Dexmedetomidine is an α2-adrenergic receptor agonist used for its sympatholytic effect, providing sedation, analgesia, and cardiovascular stabilization in the perioperative period. Remifentanil is a µ opioid agonist with a rapid onset and short duration of action, which is degraded by plasma esterase in tissues. Investigators aimed to compare the effects of dexmedetomidine and remifentanil infusions on sedation quality, side effects, and surgeon's satisfaction in geriatric outpatients who underwent cataract surgery.
详细描述
Dexmedetomidine is an α2 agonist and remifentanil is a short-acting μ, opioid agonist. The aim of this study was to compare dexmedetomidine and remifentanil infusions used for conscious sedation in geriatric patients undergoing outpatient cataract surgery in terms of sedation quality, hemodynamic stability, and surgeon satisfaction.
Eighty patients were divided into two groups according to the administration of dexmedetomidine (Group D) and remifentanil (Group R) infusion in this randomized, prospective, double-blinded study. In group D (n = 40), after a loading of 1 µg/kg dexmedetomidine in 10 minutes, 0.4 µg/kg/h-1 infusion was administered. In Group R (n = 40), remifentanil at a dose of 0.05 µg/kg-1 was administered for 10 minutes, and then 0.05 µg/kg/min-1 infusion was continued.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The surgeon who performed the surgery, the participants included in the study, and the technician who collected the study data were unaware of the study groups and the type of drugs used for sedation.
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between the ages of 65-80,
- •Who will undergo cataract surgery,
- •With the American Society of Anesthesiologists (ASA) score I-III.
排除标准
- •Second or third-degree heart block,
- •Chronic α2-agonist use,
- •Inability to communicate with the patient,
- •Uncontrolled systemic disease,
- •Allergy to local anesthetics,
- •Chronic analgesic or sedative drug use,
- •History of alcohol or substance addiction.
研究组 & 干预措施
Dexmedetomidine infusion
Dexmedetomidine (Precedex, Meditera, USA) was administered at a loading dose of 1 µg/kg for 10 minutes before local anesthesia to be applied to the eye by the surgeon. During the surgical procedure, it was administered at a dose of 0.4 µg/kg/h-1 infusion.
干预措施: Dexmedetomidine infusion (Drug)
Remifentanil infusion
Remifentanil (Ultiva, Glaxo SmithKline, Turkey) infusion was started at a dose of 0.05 µg/kg/min-1, 10 minutes before the start of the surgery as baseline infusion and continued at the same infusion dose throughout the surgical procedure.
干预措施: Remifentanil infusion (Drug)
结局指标
主要结局
Sedation level
时间窗: The time interval immediately after the surgery starts and immediately after the surgery ends.
Bispectral Index (BIS) was used to determine the sedation level of each patient. The minimum and maximum values for BIS were between 0 and 100. Lower scores mean a deep sedation level.
Pain intensity
时间窗: The time interval between the start of the surgery and the end of the surgery.
The Verbal Rating Scale was used to determine severity of the pain in the perioperative period. VRS is a 5-point scale including expressions defining the level of pain intensity (no pain, mild pain, moderate pain, intense pain and maximum pain). Higher scores mean intense pain.
Sedation quality
时间窗: Time interval immediately after the start of the surgery and before the patient is transferred to the postoperative care unit.
The Observer Assessment Warning/Sedation Scale (OAA/S) was used to determine the sedation quality of each patient. The minimum and maximum values of OAA/S scale was between 0 and 5. Lower scores mean a better sedation quality.
次要结局
- Surgeon's satisfaction(Immediately after the surgeon finishes the operation.)
- Side effects(The time interval between the start and the end of the surgery.)
- Pain intensity(Immediately after the surgical procedure is completed and the patient is transferred to the postoperative care unit and before the patient is transferred to the outpatient service.)
研究者
Ozkan Onal
Associate Professor
Selcuk University