Intranasal Dexmedetomidine on Blood Pressure in Elderly Hypertensive Patients Undergoing Cataract Surgery

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Cataract, Hypertension

In brief

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.

Key facts

Study ID

NCT07080229

Run by

Suez Canal University

People needed

126

Starts

2025-07-16

Expected to finish

2026-05-01

Last updated by the study team

2026-04-07

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Suez Canal University Hospitals — Ismailia, Ismailia Governorate, Egypt (enrolling)

Full record on ClinicalTrials.gov

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