Different Administration Routes of Dexmedetomidine on Postoperative Delirium

• Sponsor: Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05952050
• Collaborator: Zhongshan Hospital Of Traditional Chinese Medicine (Other)
• Enrollment: 120
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 2
• Patients Per Site Per Month: 60.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dexmedetomidine; Postoperative Delirium; General Anesthesia	Drug: Dexmedetomidine	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Effect of Different Administration Routes of Dexmedetomidine on Postoperative Delirium in Elderly Patients Undergoing General Anesthesia
• Anticipated Study Start Date: Aug 1, 2023
• Anticipated Primary Completion Date: Aug 1, 2023
• Anticipated Study Completion Date: Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intranasal dexmedetomidine	Drug: Dexmedetomidine; Different Administration Routes of Dexmedetomidine
Active Comparator: Intravenous dexmedetomidine	Drug: Dexmedetomidine; Different Administration Routes of Dexmedetomidine

Outcome Measures

Primary Outcome Measures

1. The frequency of delirium during the first 3 postoperative days [3 days]

Secondary Outcome Measures

1. The incidence of postoperative sore throat [3 days]

2. The incidence of sleep quality [3 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Weitao Chen	Zhongshan	Guangdong	China	528000

Sponsors and Collaborators

• Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd.
• Zhongshan Hospital Of Traditional Chinese Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05952050
• Other Study ID Numbers: US2023001
• First Posted: Jul 19, 2023
• Last Update Posted: Jul 19, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Delirium; Emergence Delirium; Dexmedetomidine

Study Results

No Results Posted as of Jul 19, 2023