Postoperative Infusion of Dexmedetomidine for Prevention of Postoperative Delirium in Elderly Patients Undergoing Lung Surgery: A Randomized Controlled Trial

Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd.1 site in 1 country287 target enrollmentNovember 11, 2023

ConditionsDelirium in Old Age Anesthesia; Adverse Effect

InterventionsDexmedetomidine injection Sufentanil injection

DrugsDexmedetomidine injection Sufentanil injection

Overview

Phase: Not Applicable
Intervention: Dexmedetomidine injection
Conditions: Delirium in Old Age
Sponsor: Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd.
Enrollment: 287
Locations: 1
Primary Endpoint: Incidence of postoperative delirium
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this clinical trial is to learn how postoperative infusion of dexmedetomidine would influence postoperative delirium in elderly patients undergoing lung surgery. The main questions it aims to answer are :

Does postoperative dexmedetomidine reduce the incidence of delirium after lung surgery?
Does postoperative dexmedetomidine introduce other medical problems? Researchers will compare dexmedetomidine and sufentanil to see if dexmedetomidine works to reduce delirium.

Participants will undergo routine postoperative care:

Patient-controlled self anesthesia with sufentanil only or combination of sufentanil and dexmedetomidine
Postoperative visit twice a day for at least seven days

Registry

clinicaltrials.gov

Start Date

November 11, 2023

End Date

April 28, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•elective surgery for lobectomy or segmentectomy

Exclusion Criteria

•local allergy to anesthetics;
•patients with a clear preoperative history of nervous system and mental system diseases or long-term use of sedatives or antidepressants;
•history of alcoholism, drug abuse or drug dependence;
•have a history of brain surgery or injury;
•epilepsy and associated mental and cognitive dysfunction, long-term stress stimulation, or psychological disorders;
•sick sinus syndrome, second-degree or greater atrioventricular block or other contraindications for use of α2 adrenergic agonist;
•liver and kidney insufficiency.

Arms & Interventions

Experiment

Intervention: Dexmedetomidine injection

Control

Intervention: Sufentanil injection

Outcomes

Primary Outcomes

Incidence of postoperative delirium

Time Frame: Delirium is assessed at 8 am and 8 pm for 3 days after surgery

Secondary Outcomes

Incidence of postoperative nausea and vomiting(Assessed twice a day for 7days after surgery)
incidence of postoperative complications(Assessed daily for 3 days after surgery)
Pain intensities(Assessed daily at 8 am for 3 days after surgery)