Cataract, Hypertension
Conditions
Keywords
Cataract, Hypertension, Intranasal Dexmedetomidine, Elderly
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.
Interventions
DRUGIntranasal 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.
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.
Sponsors
Suez Canal University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Sedation score 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 |
| 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 |
| Patient Satisfaction | Assessed once the patient is in the post-anesthesia care unit (PACU) prior to discharge | 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. |
| Anesthesiologist Satisfaction | Assessed immediately after completion of the procedure | 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. |
| Surgeon Satisfaction | Assessed immediately after completion of the procedure | 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. |
Countries
Egypt
Contacts
CONTACTMohammad E Salama, MD
CONTACTAbdelrhman M Alshawadfy, MD
Outcome results
None listed