The Effect of Intranasal Dexmedetomidine Compared to Placebo on Blood Pressure in Elderly Hypertensive Patients Undergoing Cataract Surgery: A Double-Blind Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Mean arterial blood pressure (MAP)
研究概览
简要总结
Cataract surgery in elderly patients with controlled hypertension carries a risk of hemodynamic instability, particularly fluctuations in mean arterial blood pressure (MAP). Dexmedetomidine, a selective α2-adrenergic agonist, offers hemodynamic stabilization and sedation when administered intranasally and provides a simple and non-invasive premedication option.
This study evaluates the effects of intranasal dexmedetomidine on perioperative mean arterial blood pressure in patients undergoing cataract surgeries.
Research Question:
Does intranasal dexmedetomidine premedication control blood pressure in elderly hypertensive patients undergoing cataract surgery?
Research Hypothesis:
Intranasal dexmedetomidine significantly reduces MAP and improves secondary outcomes compared to placebo.
Primary Objective: To evaluate the efficacy of intranasal Dexmedetomidine as a premedication to control hypertension in elderly patients scheduled for cataract surgery.
Secondary Objectives: 1. To assess surgery cancellation rates. 2. To evaluate satisfaction levels among patients, anesthesiologists, and surgeons using the Modified Observer's assessment of alertness/sedation scale (MOAA/S). 3- To evaluate the effect of intranasal dexmedetomidine on HR multiple readings starting from preoperative hold area till 2 hours postoperatively.
This randomized, double-blinded clinical trial will include 126 elderly hypertensive patients (≥65 years) undergoing cataract surgery under local anesthesia. Inclusion Criteria will consist of patients aged ≥65 years, ASA II or III, stage 2 hypertension as per ACC / AHA guidelines (SBP>140 and DBP> 90 mmHg), undergoing elective cataract surgery under local anesthesia. Exclusion Criteria will include allergy or contraindication to dexmedetomidine, significant baseline bradycardia (<50 bpm) or arrhythmia, use of sedative or anxiolytic medications, history of severe hepatic, renal, or cerebrovascular disease. Participants will be randomly assigned to receive either intranasal dexmedetomidine (1 mcg/kg ideal body weight) or a placebo (normal saline) 30 minutes before surgery. MAP, HR, and SpO₂ will be recorded at multiple perioperative intervals, and surgical cancellation rates, satisfaction levels will be noted, surgical duration, and hospital stay will be documented.
详细描述
Intranasal Administration Technique:
- Intranasal dexmedetomidine (1 mcg/kg ideal body weight) will be diluted to a total volume of 1 ml.
- A mucosal atomization device (MAD) will be used for administration.
- The dose will be divided evenly, with 0.5 mL sprayed into each nostril while the patient is in a semi-recumbent position.
- The control group will receive an equivalent volume of 0.9% saline using the same method.
Local Anesthesia A peribulbar block will be administered with a mixture of lidocaine 2% and bupivacaine 0.5% (total volume: 5 mL).
The block will be performed under aseptic conditions by an experienced anesthesiologist.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥65 years.
- •Patients who will have stage 2 hypertension as per ACC/AHA guidelines (Systolic BP > 140 and Diastolic BP> 90 mmHg)
- •Elective cataract surgery under local anesthesia.
- •American Society of Anesthesiologists (ASA) physical status II or III.
排除标准
- •Allergy or contraindication to dexmedetomidine.
- •Significant baseline bradycardia (<50 bpm) or arrhythmias.
- •Use of sedative or anxiolytic medications.
- •History of severe hepatic, renal, or cerebrovascular diseases.
研究组 & 干预措施
Dexmedetomidine group (Study group)
In this group, Dexmedetomidine (1 mcg/kg ideal body weight) will be administered intranasally 30 minutes before surgery.
干预措施: Intranasal dexmedetomidine (Drug)
Placebo group (Control group)
In this group, Normal Saline will be administered intranasally 30 minutes before surgery.
干预措施: Intranasal normal saline (Drug)
结局指标
主要结局
Mean arterial blood pressure (MAP)
时间窗: From preoperative baseline until 2 hours postoperatively
Mean arterial blood pressure (MAP), measured in mmHg, will be recorded in both groups at the following time points: * Preoperative baseline * Every 5 minutes after intranasal drug administration * Intraoperative baseline * Immediately after peribulbar block * Every 5 minutes after the block until the end of the surgery * Every 15 minutes postoperatively until discharge
次要结局
- Satisfaction score of patient, anesthesiologist, and surgeon using the Modified Observer's Assessment of Alertness/Sedation Scale (MOAA/S).(From preoperative drug administration until 2 hours postoperatively)
- Surgical cancellation rate(From the preoperative period until completion or cancellation of the surgery)
- Heart rate (HR)(From preoperative baseline until 2 hours postoperatively)
研究者
Mohammad E Salama, MD
Principal investigator
Suez Canal University