Intranasal Dexmedetomidine for Adult Patients Undergoing Phacoemulsification Cataract Surgery

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cataract; Preoperative Sedation
• Intervention / Treatment: Drug: Dextrometropine and 0.9% sodium chloride solution

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 Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510180
      • Recruiting
      • Guangzhou First People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Guangzhou First People's Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 10, 2023
• Primary Completion (ANTICIPATED): March 31, 2023
• Study Completion (ANTICIPATED): March 31, 2023

Study Registration Dates

• First Submitted: January 16, 2023
• First Submitted That Met QC Criteria: January 16, 2023
• First Posted (ACTUAL): January 26, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 4, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Patient satisfaction; Cataract; Preoperative sedation; Dextromethoridine
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: K-2022-160-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No