Clinical trial

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

Name

K-2022-160-01

Description

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.

Trial arms

Trial start

2023-01-10

Estimated PCD

2023-03-31

Trial end

2023-03-31

Status

Recruiting

Treatment

Dextrometropine and 0.9% sodium chloride solution

Intranasal dexmedetomidine or 0.9% sodium chloride solution as a sedative premedication for patients undergoing cataract surgery

Arms:

dextrometropine group, placebo group

Other names:

Dexmedetomidine Hydrochloride

Size

Primary endpoint

Overall patients satisfaction with preoperative sedation

Operation day

Anxiety of perioperative patients

Operation day

Eligibility criteria

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. -

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 64, 'type': 'ESTIMATED'}}

Updated at

2023-02-08

1 organization

1 product

2 indications

Organization

Guangzhou First People's Hospital

Product

Dextrometropine

Indication

Cataract

Indication

Preoperative Sedation