Postoperative Dexmedetomidine in Prevention of Postoperative Delirium

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

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

Study Overview

• Status: Completed
• Conditions: Delirium in Old Age; Anesthesia; Adverse Effect
• Intervention / Treatment: Drug: Dexmedetomidine injection; Drug: Sufentanil injection

• Study Type: Interventional
• Enrollment (Actual): 287
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Yunnan
    • Kunming, Yunnan, China, 650100
      • Kunming Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control	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.
Experimental: Experiment	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of postoperative delirium	Delirium is assessed at 8 am and 8 pm for 3 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative nausea and vomiting		Assessed twice a day for 7days after surgery
incidence of postoperative complications	Other postoperative complications including including hypotension, hypertension, bradycardia, tachycardia, and hypoxemia	Assessed daily for 3 days after surgery
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

Collaborators and Investigators

• Sponsor: Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd.
• Collaborators: Shenzhen People's Hospital; Kunming Children's Hospital; Dongyuan People's Hospital
• Investigators: Study Director: Rui Zhao, Department of Anesthesiology, Kunming Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2023
• Primary Completion (Actual): March 6, 2024
• Study Completion (Actual): April 28, 2024

Study Registration Dates

• First Submitted: April 22, 2024
• First Submitted That Met QC Criteria: April 23, 2024
• First Posted (Actual): April 25, 2024

Study Record Updates

• Last Update Posted (Actual): May 24, 2024
• Last Update Submitted That Met QC Criteria: May 22, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Emergence Delirium; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Adjuvants, Anesthesia; Dexmedetomidine; Sufentanil
• Other Study ID Numbers: SZUS_231101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No