Back to resultsDifferent Administration Routes of Dexmedetomidine on Postoperative Delirium
Primary Purpose
Dexmedetomidine, Postoperative Delirium, General Anesthesia
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Dexmedetomidine
Sponsored by
About this trial
This is an interventional treatment trial for Dexmedetomidine
Eligibility Criteria
Inclusion Criteria: Older than 65 years; General anesthesia for more than two hours; Exclusion Criteria: -
Sites / Locations
- Weitao ChenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intranasal dexmedetomidine
Intravenous dexmedetomidine
Arm Description
Outcomes
Primary Outcome Measures
The frequency of delirium during the first 3 postoperative days
Secondary Outcome Measures
The incidence of postoperative sore throat
The incidence of sleep quality
Full Information
NCT ID
NCT05952050
First Posted
July 11, 2023
Last Updated
July 11, 2023
Sponsor
Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd.
Collaborators
Zhongshan Hospital Of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05952050
Brief Title
Different Administration Routes of Dexmedetomidine on Postoperative Delirium
Official Title
Effect of Different Administration Routes of Dexmedetomidine on Postoperative Delirium in Elderly Patients Undergoing General Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd.
Collaborators
Zhongshan Hospital Of Traditional Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dexmedetomidine, Postoperative Delirium, General Anesthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intranasal dexmedetomidine
Arm Type
Experimental
Arm Title
Intravenous dexmedetomidine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
Different Administration Routes of Dexmedetomidine
Primary Outcome Measure Information:
Title
The frequency of delirium during the first 3 postoperative days
Time Frame
3 days
Secondary Outcome Measure Information:
Title
The incidence of postoperative sore throat
Time Frame
3 days
Title
The incidence of sleep quality
Time Frame
3 days
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Older than 65 years; General anesthesia for more than two hours;
Exclusion Criteria:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weitao Chen
Phone
18025661798
Email
540138690@qq.com
Facility Information:
Facility Name
Weitao Chen
City
Zhongshan
State/Province
Guangdong
ZIP/Postal Code
528000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weitao Chen, MD
Phone
18025661798
Email
540138690@qq.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Different Administration Routes of Dexmedetomidine on Postoperative Delirium
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