Postoperative Dexmedetomidine in Prevention of Postoperative Delirium

Not Applicable

Completed

• Conditions: Anesthesia; Adverse Effect; Delirium in Old Age
• Interventions: Drug: Dexmedetomidine injection; Drug: Sufentanil injection

• Registration Number: NCT06382961
• Lead Sponsor: Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd.

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 :

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-11
• Primary Completion: 2024-03-06
• Study First Submitted: 2024-04-22
• Study First Submitted QC: 2024-04-23
• Study First Posted: 2024-04-25
• Study Completion: 2024-04-28
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-22
• Last Update Posted: 2024-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 287

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experiment	Dexmedetomidine injection	-
Control	Sufentanil injection	-

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative delirium	Delirium is assessed at 8 am and 8 pm for 3 days after surgery

Secondary Outcome Measures

Name	Time	Method
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	Other postoperative complications including including hypotension, hypertension, bradycardia, tachycardia, and hypoxemia
Pain intensities	Assessed daily at 8 am for 3 days after surgery	patient pain assessed using numeric rating scale, ranged from 0 to 11, higher score indicate higher pain intensity

Trial Locations

Locations (1)

Kunming Children's Hospital; 🇨🇳 Kunming, Yunnan, China