NCT07080229 Intranasal Dexmedetomidine on Blood Pressure in Elderly Hypertensive Patients Undergoing Cataract Surgery
| NCT ID | NCT07080229 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Suez Canal University |
| Condition | Cataract |
| Study Type | INTERVENTIONAL |
| Enrollment | 126 participants |
| Start Date | 2025-07-16 |
| Primary Completion | 2026-04 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 126 participants in total. It began in 2025-07-16 with a primary completion date of 2026-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Patients aged ≥65 years. 2. Patients who will have stage 2 hypertension as per ACC/AHA guidelines (Systolic BP \> 140 and Diastolic BP\> 90 mmHg) 3. Elective cataract surgery under local anesthesia. 4. American Society of Anesthesiologists (ASA) physical status II or III. Exclusion Criteria: 1. Allergy or contraindication to dexmedetomidine. 2. Significant baseline bradycardia (\<50 bpm) or arrhythmias. 3. Use of sedative or anxiolytic medications. 4. History of severe hepatic, renal, or cerebrovascular diseases.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07080229 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Cataract. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07080229 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 126 participants.
Is NCT07080229 currently recruiting?
Yes, NCT07080229 is actively recruiting participants. Contact the research team at MohammadElhossieny88@med.suez.edu.eg for enrollment information.
Where is the NCT07080229 trial being conducted?
This trial is being conducted at Ismailia, Egypt.
Who is sponsoring the NCT07080229 clinical trial?
NCT07080229 is sponsored by Suez Canal University. The trial plans to enroll 126 participants.