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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-16

Study Completion Date

2026-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cataract Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dexmedetomidine group (Study group)

In this group, Dexmedetomidine (1 mcg/kg ideal body weight) will be administered intranasally 30 minutes before surgery.

Group Type ACTIVE_COMPARATOR

Intranasal dexmedetomidine

Intervention Type 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.

Placebo group (Control group)

In this group, Normal Saline will be administered intranasally 30 minutes before surgery.

Group Type PLACEBO_COMPARATOR

Intranasal normal saline

Intervention Type 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.

Interventions

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Intranasal dexmedetomidine

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.

Intervention Type DRUG

Intranasal normal saline

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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No