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Completed

NCT Number: NCT06382961

Postoperative Dexmedetomidine in Prevention of Postoperative Delirium

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

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Key information

Conditions

Delirium in Old Age Anesthesia; Adverse Effect

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kunming Children's Hospital

Kunming, Yunnan, 650100, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Incidence of postoperative delirium

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

Secondary outcomes

  1. Incidence of postoperative nausea and vomiting

    Time frame: Assessed twice a day for 7days after surgery

  2. incidence of postoperative complications

    Time frame: Assessed daily for 3 days after surgery

    Other postoperative complications including including hypotension, hypertension, bradycardia, tachycardia, and hypoxemia

  3. Pain intensities

    Time frame: 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

Sponsors and collaborators

Lead sponsor

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

Industry

Collaborators

  • Dongyuan People's Hospital
  • Kunming Children's Hospital
  • Shenzhen People's Hospital

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 25, 2024
Registry last updated
May 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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