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

Sponsor
Suez Canal University
Study ID
NCT07080229
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intranasal dexmedetomidine — DRUG
    Intranasal dexmedetomidine (1 mcg/kg ideal body weight) will be diluted to a total volume of 1 ml and will be administered via a mucosal atomization device (MAD) 30 minutes before surgery. The dose will be divided evenly, with 0.5 mL sprayed into each nostril while the patient is in a semi-recumbent position.
  • Intranasal normal saline — DRUG
    Intranasal normal saline (1 ml) will be administered via mucosal atomization device (MAD) 30 minutes before surgery. The dose will be divided evenly, with 0.5 mL sprayed into each nostril while the patient is in a semi-recumbent position.

Study Details

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 Dates

First listed
Jul 23, 2025
Start date
Jul 16, 2025
Status verified
Aug 2025
Primary completion
Apr 30, 2026
Completion
May 31, 2026

Study Design

Enrollment
126 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Dexmedetomidine group (Study group)
    In this group, Dexmedetomidine (1 mcg/kg ideal body weight) will be administered intranasally 30 minutes before surgery.
  • Placebo Comparator: Placebo group (Control group)
    In this group, Normal Saline will be administered intranasally 30 minutes before surgery.

Primary Outcome Measure

Mean arterial blood pressure (MAP) [ Time Frame: From preoperative baseline until 2 hours postoperatively ]

Central Contacts

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