Postoperative Dexmedetomidine in Prevention of Postoperative Delirium

NCT06382961 | Completed

• 1 other identifier: SZUS_231101
• Study Type: interventional
• Target: 287
• Locations: 1 country
• Sites: 1

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. 1.Does postoperative dexmedetomidine reduce the incidence of delirium after lung surgery?
2. 2.Does postoperative dexmedetomidine introduce other medical problems? Researchers will compare dexmedetomidine and sufentanil to see if dexmedetomidine works to reduce delirium.
3. 3.Patient-controlled self anesthesia with sufentanil only or combination of sufentanil and dexmedetomidine
4. 4.Postoperative visit twice a day for at least seven days

Conditions

Delirium in Old Age; Anesthesia; Adverse Effect

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative delirium

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

Secondary Outcomes (3)

• 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

Study Arms (2)

Experiment

EXPERIMENTAL

Drug: Dexmedetomidine injection

Control

ACTIVE COMPARATOR

Drug: Sufentanil injection

Interventions

Dexmedetomidine injection DRUG

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.

Experiment

Sufentanil injection DRUG

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.

Control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• elective surgery for lobectomy or segmentectomy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd.: lead
• Shenzhen People's Hospital: collaborator
• Dongyuan People's Hospital: collaborator
• Kunming Children's Hospital: collaborator

Study Sites (1)

Kunming Children's Hospital

Kunming, Yunnan, 650100, China

Location

MeSH Terms

Interventions

Dexmedetomidine; Sufentanil

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fentanyl; Piperidines

Study Officials

• Rui Zhao

  Department of Anesthesiology, Kunming Children's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 25, 2024
• Study Start: November 11, 2023
• Primary Completion: March 6, 2024
• Study Completion: April 28, 2024
• Last Updated: May 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)