An interventional study of Dextrometropine and 0.9% sodium chloride solution in Cataract and Preoperative Sedation, sponsored by Guangzhou First People's Hospital. Status unknown at 1 site in China. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2023-02-08.
Sponsored by Guangzhou First People's Hospital · Not applicable, Interventional, and Treatment
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.
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.
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's planned enrollment of 64 is below the median of 80 across 1,155 interventional studies indexed under Cataract.
Browse Cataract studies →Guangzhou First People's Hospital is the lead sponsor of 25 studies on the registry; 5 are open to participants now.
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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.
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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
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
Intranasal dexmedetomidine or 0.9% sodium chloride solution as a sedative premedication for patients undergoing cataract surgery
Also known as: Dexmedetomidine Hydrochloride
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.
Time frame: 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.
Time frame: Operation day
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
Time frame: Perioperative period
Plan to share: No
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This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Guangzhou First People's Hospital