The Effect of Intranasal Dexmedetomidine Compared to Placebo on Blood Pressure in Elderly Hypertensive Patients Undergoing Cataract Surgery: A Double-Blind Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Egypt
Suez Canal University Hospitals
RECRUITING
Ismailia
Contact Information
Primary
Mohammad E Salama, MD
MohammadElhossieny88@med.suez.edu.eg
+201016865861
Backup
Abdelrhman M Alshawadfy, MD
abdelrhmanalshawadfy@gmail.com
+201091091620
Time Frame
Start Date: 2025-07-16
Estimated Completion Date: 2026-01
Participants
Target number of participants: 126
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Suez Canal University

This content was sourced from clinicaltrials.gov