Intranasal Dexmedetomidine for Adult Patients Undergoing Phacoemulsification Cataract Surgery

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05698758
• Other study ID #: K-2022-160-01
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2023
• Est. completion date: March 31, 2023

Study information

• Verified date: February 2023
• Source: Guangzhou First People's Hospital
• Contact: Yuehong Zhang, PhD
• Phone: 86-02081048225
• Email: carmenzhangyh[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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 a-methyldopa, clonidine, or other a2-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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Related Conditions & MeSH terms

• Cataract
• Preoperative Sedation

Intervention

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

Locations

Country	Name	City	State
China	Guangzhou First People's Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou First People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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