NCT05952050

Brief Summary

Intravenous dexmedetomidine has been reported to decrease the occurrence of postoperative delirium (POD) in elderly patients. Nevertheless, some previous studies have indicated that intratracheal dexmedetomidine and intranasal dexmedetomidine are also effective and convenient. The current study aimed to compare the effect of different administration routes of dexmedetomidine on POD in elderly patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 19, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

July 19, 2023

Status Verified

July 1, 2023

Enrollment Period

Same day

First QC Date

July 11, 2023

Last Update Submit

July 11, 2023

Conditions

DexmedetomidinePostoperative DeliriumGeneral Anesthesia

Outcome Measures

Primary Outcomes (1)

  • The frequency of delirium during the first 3 postoperative days

    3 days

Secondary Outcomes (2)

  • The incidence of postoperative sore throat

    3 days

  • The incidence of sleep quality

    3 days

Study Arms (2)

Intranasal dexmedetomidine

EXPERIMENTAL
Drug: Dexmedetomidine

Intravenous dexmedetomidine

ACTIVE COMPARATOR
Drug: Dexmedetomidine

Interventions

DexmedetomidineDRUG

Different Administration Routes of Dexmedetomidine

Intranasal dexmedetomidineIntravenous dexmedetomidine

Eligibility Criteria

Age65 Years - 99 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Older than 65 years; General anesthesia for more than two hours;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weitao Chen

Zhongshan, Guangdong, 528000, China

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Weitao Chen

CONTACT

18025661798540138690@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2023

First Posted

July 19, 2023

Study Start

August 1, 2023

Primary Completion

August 1, 2023

Study Completion

September 30, 2023

Last Updated

July 19, 2023

Record last verified: 2023-07

Locations

CN(1)