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

NCT07080229 | Recruiting Phase 3

• 1 other identifier: 5989#
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract; Hypertension

Keywords

Cataract; Hypertension; Intranasal Dexmedetomidine; Elderly

Outcome Measures

Primary Outcomes (1)

• Mean arterial blood pressure (MAP)

  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

  From preoperative baseline until 2 hours postoperatively

Secondary Outcomes (3)

• Surgical cancellation rate

  From the preoperative period until completion or cancellation of the surgery

• 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

• Heart rate (HR)

  From preoperative baseline until 2 hours postoperatively

Study Arms (2)

Dexmedetomidine group (Study group)

ACTIVE COMPARATOR

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

Drug: Intranasal dexmedetomidine

Placebo group (Control group)

PLACEBO COMPARATOR

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

Drug: Intranasal normal saline

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.

Dexmedetomidine group (Study group)

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.

Placebo group (Control group)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Allergy or contraindication to dexmedetomidine.
• Significant baseline bradycardia (\<50 bpm) or arrhythmias.
• Use of sedative or anxiolytic medications.
• History of severe hepatic, renal, or cerebrovascular diseases.

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Suez Canal University Hospitals

Ismailia, Ismailia Governorate, 41522, Egypt

RECRUITING

Related Publications (6)

• Wang K, Wu M, Xu J, Wu C, Zhang B, Wang G, Ma D. Effects of dexmedetomidine on perioperative stress, inflammation, and immune function: systematic review and meta-analysis. Br J Anaesth. 2019 Dec;123(6):777-794. doi: 10.1016/j.bja.2019.07.027. Epub 2019 Oct 24.

  PMID: 31668347 BACKGROUND

• Rawlins JM, Segree W. Suggestions for increased job satisfaction for doctors and for improved patient care. West Indian Med J. 1984 Jun;33(2):87-91. No abstract available.

  PMID: 6485320 BACKGROUND

• Xu X, Cao Y, Wu Y, Ding M. Intranasal Dexmedetomidine in Elderly Patients (Aged > 65 Years) During Maxillofacial Surgery: Sedative Properties and Safety Analysis. J Oral Maxillofac Surg. 2022 Mar;80(3):443-455. doi: 10.1016/j.joms.2021.10.013. Epub 2021 Oct 30.

  PMID: 34838503 BACKGROUND

• Li A, Yuen VM, Goulay-Dufay S, Sheng Y, Standing JF, Kwok PCL, Leung MKM, Leung AS, Wong ICK, Irwin MG. Pharmacokinetic and pharmacodynamic study of intranasal and intravenous dexmedetomidine. Br J Anaesth. 2018 May;120(5):960-968. doi: 10.1016/j.bja.2017.11.100. Epub 2018 Feb 2.

  PMID: 29661413 BACKGROUND

• Fleisher LA, Fleischmann KE, Auerbach AD, Barnason SA, Beckman JA, Bozkurt B, Davila-Roman VG, Gerhard-Herman MD, Holly TA, Kane GC, Marine JE, Nelson MT, Spencer CC, Thompson A, Ting HH, Uretsky BF, Wijeysundera DN. 2014 ACC/AHA guideline on perioperative cardiovascular evaluation and management of patients undergoing noncardiac surgery: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Dec 9;130(24):2215-45. doi: 10.1161/CIR.0000000000000105. Epub 2014 Aug 1. No abstract available.

  PMID: 25085962 BACKGROUND

• Fang R, Yu YF, Li EJ, Lv NX, Liu ZC, Zhou HG, Song XD. Global, regional, national burden and gender disparity of cataract: findings from the global burden of disease study 2019. BMC Public Health. 2022 Nov 12;22(1):2068. doi: 10.1186/s12889-022-14491-0.

  PMID: 36369026 BACKGROUND

MeSH Terms

Conditions

Cataract; Hypertension

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Mohammad E Salama, MD

CONTACT

+201016865861; MohammadElhossieny88@med.suez.edu.eg

Abdelrhman M Alshawadfy, MD

CONTACT

+201091091620; abdelrhmanalshawadfy@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: July 23, 2025
• Study Start: July 16, 2025
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: August 21, 2025

Record last verified: 2025-08

Locations

EG (1)