Intranasal Dexmedetomidine for Adult Patients Undergoing Phacoemulsification Cataract Surgery

NCT05698758 | Unknown DMC

• 1 other identifier: K-2022-160-01
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract; Preoperative Sedation

Keywords

Cataract; Preoperative sedation; Dextromethoridine; Patient satisfaction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Effects of preoperative sedation on patients' vital signs and operation time

  Perioperative period

Study Arms (2)

dextrometropine group

EXPERIMENTAL

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

placebo group

PLACEBO COMPARATOR

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

Interventions

Dextrometropine and 0.9% sodium chloride solution DRUG

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

Also known as: Dexmedetomidine Hydrochloride

dextrometropine group; placebo group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

Sponsors & Collaborators

• Guangzhou First People's Hospital: lead

Study Sites (1)

Guangzhou First People's Hospital

Guangzhou, Guangdong, 510180, China

RECRUITING

MeSH Terms

Conditions

Cataract; Patient Satisfaction

Interventions

Sodium Chloride; Dexmedetomidine

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yuehong Zhang, PhD

  Guangzhou First People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuehong Zhang, PhD

CONTACT

86-02081048225; carmenzhangyh@163.com

Zhimeng Zhang, PhD

CONTACT

86-02081048225; 598527019@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: January 26, 2023
• Study Start: January 10, 2023
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)