Intranasal Dexmedetomidine for Adult Patients Undergoing Phacoemulsification Cataract Surgery

Sponsor

Guangzhou First People's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05698758

Collaborator

(none)

Enrollment

Location

Arms

2.6

Anticipated Duration (Months)

24.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cataract Preoperative Sedation	Drug: Dextrometropine and 0.9% sodium chloride solution	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 10, 2023

Anticipated Primary Completion Date :

Mar 31, 2023

Anticipated Study Completion Date :

Mar 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: dextrometropine group 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 Intranasal dexmedetomidine or 0.9% sodium chloride solution as a sedative premedication for patients undergoing cataract surgery Other Names: Dexmedetomidine Hydrochloride
Placebo Comparator: placebo group 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 Other Names: Dexmedetomidine Hydrochloride

Arm

Intervention/Treatment

Experimental: dextrometropine group

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

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

Other Names:

Dexmedetomidine Hydrochloride

Placebo Comparator: placebo group

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

Other Names:

Dexmedetomidine Hydrochloride

Outcome Measures

Primary Outcome Measures

Overall patients satisfaction with preoperative sedation [Operation day]
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.
Anxiety of perioperative patients [Operation day]
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.

Secondary Outcome Measures

Effects of preoperative sedation on patients' vital signs and operation time [Perioperative period]
Blood pressure, heart rate, blood oxygen saturation, operation time, operative complications and adverse drug reactions

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.