Postoperative Dexmedetomidine in Prevention of Postoperative Delirium

Delirium in Old Age Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06382961
• Other study ID #: SZUS_231101
• Status: Completed
• Phase: N/A
• Start date: November 11, 2023
• Est. completion date: April 28, 2024

Study information

• Verified date: May 2024
• Source: Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 :

1. Does postoperative dexmedetomidine reduce the incidence of delirium after lung surgery?

2. 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:

1. Patient-controlled self anesthesia with sufentanil only or combination of sufentanil and dexmedetomidine

2. Postoperative visit twice a day for at least seven days

Recruitment information / eligibility

• Status: Completed
• Enrollment: 287
• Est. completion date: April 28, 2024
• Est. primary completion date: March 6, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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 a2 adrenergic agonist;

• liver and kidney insufficiency.

Related Conditions & MeSH terms

• Anesthesia; Adverse Effect
• Delirium
• Delirium in Old Age
• Emergence Delirium

Intervention

Drug:
• Dexmedetomidine injection
Combining with 3 µg.kg-1 sufentanil, 3 µg.kg-1 dexmedetomidine is injected through intravenous patient controlled anesthesia pump in a 2 ml bolus with 20 minutes lock-out, and a background infusion rate of 2 ml per hour.
• Sufentanil injection
3 µg.kg-1 sufentanil is injected through intravenous patient controlled anesthesia pump in a 2 ml bolus with 20 minutes lock-out, and a background infusion rate of 2 ml per hour.

Locations

Country	Name	City	State
China	Kunming Children's Hospital	Kunming	Yunnan

Sponsors (4)

Lead Sponsor	Collaborator
Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd.	Dongyuan People's Hospital, Kunming Children's Hospital, Shenzhen People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postoperative delirium		Delirium is assessed at 8 am and 8 pm for 3 days after surgery
Secondary	Incidence of postoperative nausea and vomiting		Assessed twice a day for 7days after surgery
Secondary	incidence of postoperative complications	Other postoperative complications including including hypotension, hypertension, bradycardia, tachycardia, and hypoxemia	Assessed daily for 3 days after surgery
Secondary	Pain intensities	patient pain assessed using numeric rating scale, ranged from 0 to 11, higher score indicate higher pain intensity	Assessed daily at 8 am for 3 days after surgery