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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.
Intranasal Administration Technique:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine group (Study group) | Active Comparator | In this group, Dexmedetomidine (1 mcg/kg ideal body weight) will be administered intranasally 30 minutes before surgery. |
|
| Placebo group (Control group) | Placebo Comparator | In this group, Normal Saline will be administered intranasally 30 minutes before surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean arterial blood pressure (MAP) | Mean arterial blood pressure (MAP), measured in mmHg, will be recorded in both groups at the following time points:
| From preoperative baseline until 2 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical cancellation rate | 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 | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohammad E Salama, MD | Contact | +201016865861 | MohammadElhossieny88@med.suez.edu.eg | |
| Abdelrhman M Alshawadfy, MD | Contact | +201091091620 | abdelrhmanalshawadfy@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Suez Canal University Hospitals | Recruiting | Ismailia | Ismailia Governorate | 41522 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31668347 | Result | 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. | |
| 31114165 | Result | 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. |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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|
| 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. |
|
Sedation will be evaluated using the MOAA/S scale at predefined time points:
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
|
| From preoperative drug administration until 2 hours postoperatively |
| Heart rate (HR) | Heart rate (HR) will be recorded in both groups at the following time points:
| From preoperative baseline until 2 hours postoperatively |
| Patient Satisfaction | Patient satisfaction with anesthesia care was measured using the Iowa Satisfaction with Anesthesia Scale (ISAS), a validated instrument specifically designed for monitored anesthesia care and sedation. The ISAS consists of 11 items rated on a 6-point Likert scale, with both positively and negatively worded statements. The total score was calculated as the mean of all items after appropriate reverse coding, with higher scores indicating greater satisfaction. | Assessed once the patient is in the post-anesthesia care unit (PACU) prior to discharge |
| Anesthesiologist Satisfaction | Anesthesiologist Satisfaction will be evaluated using structured 5 point Likert scale (1 = very dissatisfied, 5 = very satisfied). The assessment includes adequacy of sedation, ease of patient management, hemodynamic stability, airway safety, and overall satisfaction. A composite score will be calculated as the mean of all items, with higher scores indicating greater satisfaction. | Assessed immediately after completion of the procedure |
| Surgeon Satisfaction | Surgeon satisfaction was assessed using a structured 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied). The assessment included surgical field conditions, patient cooperation, ocular stability, ease of performing the procedure, and overall satisfaction. A composite score will be calculated as the mean of all items, with higher scores indicating greater satisfaction. | Assessed immediately after completion of the procedure |
| 34838503 | Result | 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. |
| 29661413 | Result | 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. |
| 25085962 | Result | 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. |
| 36369026 | Result | 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. |