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

Not Applicable

Not yet recruiting

• Conditions: Cataract; Hypertension
• Interventions: Drug: Intranasal dexmedetomidine; Drug: Intranasal normal saline

• Registration Number: NCT07080229
• Lead Sponsor: Suez Canal University

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.

Detailed Description

Intranasal Administration Technique:

1. Intranasal dexmedetomidine (1 mcg/kg ideal body weight) will be diluted to a total volume of 1 ml.

2. A mucosal atomization device (MAD) will be used for administration.

3. The dose will be divided evenly, with 0.5 mL sprayed into each nostril while the patient is in a semi-recumbent position.

4. 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.

Study Timeline

• Status Verified: 2025-07
• Study Start: 2025-07-01
• Study First Submitted: 2025-07-14
• Study First Submitted QC: 2025-07-14
• Last Update Submitted: 2025-07-14
• Study First Posted: 2025-07-23
• Last Update Posted: 2025-07-23
• Primary Completion: 2025-12
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 126

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine group (Study group)	Intranasal dexmedetomidine	In this group, Dexmedetomidine (1 mcg/kg ideal body weight) will be administered intranasally 30 minutes before surgery.
Placebo group (Control group)	Intranasal normal saline	In this group, Normal Saline will be administered intranasally 30 minutes before surgery.

Primary Outcome Measures

Name	Time	Method
Mean arterial blood pressure (MAP)	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

Secondary Outcome Measures

Name	Time	Method
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	Sedation will be evaluated using the MOAA/S scale at predefined time points: * 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; The MOAA/S is a scale from 0 to 5 assessing a subject's responsiveness to verbal and physical stimuli as follows: 0: No response after painful stimuli; 1. Responds only after painful trapezius squeeze; 2. Responds only after mild prodding or shaking; 3. Responds only after name is called loudly and/or repeatedly; 4. Lethargic response to name spoken in normal tone; 5. Responds readily to name spoken in normal tone
Surgical cancellation rate	From the preoperative period until completion or cancellation of the surgery	The number and percentage of cases in each group in which cataract surgery will be cancelled due to uncontrolled blood pressure, inadequate sedation, patient anxiety, or any other reason
Heart rate (HR)	From preoperative baseline until 2 hours postoperatively	Heart rate (HR) 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

Trial Locations

Locations (1)

Suez Canal University Hospitals; 🇪🇬 Ismailia, Egypt