Intranasal Dexmedetomidine for Adult Patients Undergoing Phacoemulsification Cataract Surgery

Study Overview
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Brief Summary
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The investigators designed this study to examine whether the intranasal dexmedetomidine, as a preoperative drug, could improve the satisfaction of adult patients undergoing phacoemulsification cataract surgery.

Detailed Description
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This is a prospective, double-blind, randomized controlled study. Patients over 65 years old were selected for phacoemulsification combined with intraocular lens implantation under topical anesthesia. Participants were randomly divided into two groups: dextrometropine group and placebo group, and were masked until the end of this study. Approximately 45 - 60 minutes before surface anesthesia, patients in the dextrometropine group were given dextrometropine (1.0μg.kg-1), patients in the placebo group were given the same amount of saline. The primary end point of this study is the patient satisfaction. Patient satisfaction was assessed using a 3-point satisfaction score on a scale. Anxiety of perioperative patients was assessed using a 4-point anxiety score on a scale. Secondary endpoints include blood pressure, heart rate, blood oxygen saturation, operation time, operative complications and adverse drug reactions.

Official Title
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A Randomized Controlled Trial of Intranasal Dexmedetomidine for Adult Patients Undergoing Phacoemulsification Cataract Surgery

Conditions
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Cataract, Preoperative Sedation

Intervention / Treatment
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* Drug: Dextrometropine and 0.9% sodium chloride solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cataract patients over 65 years scheduled for elective phacoemulsification and intraocular lens implantation in Department of Ophthalmology, Guangzhou First People's Hospital will be recruited in this study. Recruited patients shall own normal intelligence and understanding capability and their best corrected visual acuity more than 0.1 in either eye. Exclusion Criteria: 1) a known allergy or hypersensitivity to dextrometropine or other anesthetics; 2) a previous history of heart disease; 3) a heart rate (HR) <45 beats per minute (bpm); 4) a second- or third-degree atrioventricular block; 5) patients on antihypertensive drugs, such as α-methyldopa, clonidine, or other α2-adrenergic agonists; 6) asthma; 7) sleep apnea syndrome; 8) organ dysfunction; 9) patients with mental illness; and 10) the long-term use of sedatives and analgesics. -

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dextrometropine group<br>Approximately 45 - 60 minutes before cataract surgery, patients in the dextrometropine group were given dextrometropine (1.0μg.kg-1). | Drug: Dextrometropine and 0.9% sodium chloride solution<br>* Intranasal dexmedetomidine or 0.9% sodium chloride solution as a sedative premedication for patients undergoing cataract surgery<br>* Other names: Dexmedetomidine Hydrochloride;|
| Placebo Comparator: placebo group<br>Approximately 45 - 60 minutes before cataract surgery, patients in the placebo group were given 0.9% sodium chloride solution (1.0μg.kg-1). | Drug: Dextrometropine and 0.9% sodium chloride solution<br>* Intranasal dexmedetomidine or 0.9% sodium chloride solution as a sedative premedication for patients undergoing cataract surgery<br>* Other names: Dexmedetomidine Hydrochloride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall patients satisfaction with preoperative sedation | Patient satisfaction was assessed using a 3-point satisfaction score on a scale (1 = highly satisfactory, 2 = acceptable, and 3 = unacceptable). The minimum value is 1 and maximum is 3. Higher scores mean a worse outcome. | Operation day | 
| Anxiety of perioperative patients | Anxiety of perioperative patients was assessed using a 4-point anxiety score (1 = combative, 2 = anxious, 3 = calm, and 4 = amiable). The minimum value is 1 and maximum is 4. Higher scores mean a better outcome. | Operation day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of preoperative sedation on patients' vital signs and operation time | Blood pressure, heart rate, blood oxygen saturation, operation time, operative complications and adverse drug reactions | Perioperative period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cataract, Preoperative sedation, Dextromethoridine, Patient satisfaction