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

Official title

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

Overview

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.

Interventions

• Drug 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.
• 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.

Primary outcome measures

• Mean arterial blood pressure (MAP) [Time frame: From preoperative baseline until 2 hours postoperatively]

Secondary outcome measures (6)

• Surgical cancellation rate [Time frame: From the preoperative period until completion or cancellation of the surgery]
• Sedation score using the Modified Observer's Assessment of Alertness/Sedation Scale (MOAA/S). [Time frame: From preoperative drug administration until 2 hours postoperatively]
• Heart rate (HR) [Time frame: From preoperative baseline until 2 hours postoperatively]
• Patient Satisfaction [Time frame: Assessed once the patient is in the post-anesthesia care unit (PACU) prior to discharge]
• Anesthesiologist Satisfaction [Time frame: Assessed immediately after completion of the procedure]
• Surgeon Satisfaction [Time frame: Assessed immediately after completion of the procedure]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Prevention

Study locations

Egypt · 1 center

• Suez Canal University Hospitals — Ismailia

Publications

• 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
• Liu S, Wang Y, Zhu Y, Yu T, Zhao H. Safety and sedative effect of intranasal dexmedetomidine in mandibular third molar surgery: a systematic review and meta-analysis. Drug Des Devel Ther. 2019 Apr 23;13:1301-1310. doi: 10.2147/DDDT.S194894. eCollection 2019. PMID 31114165
• 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
• 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
• 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 Card PMID 25085962
• 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

Identifiers

NCT: NCT07080229 · 5989#

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗