Delirium in Old Age, Anesthesia; Adverse Effect
Conditions
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
Interventions
DRUGDexmedetomidine 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.
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.
Sponsors
Shenzhen People's Hospital
Dongyuan People's Hospital
Kunming Children's Hospital
Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of postoperative delirium | Delirium is assessed at 8 am and 8 pm for 3 days after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Outcome results
None listed