Postoperative Dexmedetomidine in Prevention of Postoperative Delirium

NCT ID: NCT06382961

Last Updated: 2024-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 287 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-11
• Study Completion Date: 2024-04-28

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

Conditions

Delirium in Old Age; Anesthesia; Adverse Effect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Experiment

Group Type: EXPERIMENTAL

Dexmedetomidine injection

Intervention Type: 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.

Control

Group Type: ACTIVE_COMPARATOR

Sufentanil injection

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenzhen People's Hospital

OTHER

Sponsor Role: collaborator

Dongyuan People's Hospital

UNKNOWN

Sponsor Role: collaborator

Kunming Children's Hospital

OTHER

Sponsor Role: collaborator

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rui Zhao

Role: STUDY_DIRECTOR

Department of Anesthesiology, Kunming Children's Hospital

Locations

Kunming Children's Hospital

Kunming, Yunnan, China

Countries

China

Other Identifiers

SZUS_231101

Identifier Type: -

Identifier Source: org_study_id