Clinical trial NCT05168280: Intraoperative Infusion of Dexmedetomidine for Prevention of Postoperative Delirium in Elderly Patients
Official title: Intraoperative Infusion of Dexmedetomidine for Prevention of Postoperative Delirium in Elderly Patients Undergoing Craniotomy: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dexmedetomidine
Postoperative Delirium
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2021-12-23
Enrollment: 420
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Postoperative delirium (POD) is a common surgical complication. The incidence is 10% to 22% in neurological procedures, and advanced age is a risk factor for neurological procedures. Many studies have shown that dexmedetomidine(DEX) may reduce the incidence of delirium in non-cardiac surgery patients and elderly patients. However, there are few studies focus on the effect of DEX on POD in elderly patients undergoing neurosurgery. The purpose of this study was to investigate the effect of DEX on POD in in elderly patients undergoing craniotomy.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing selective craniotomy.
* Age ≥65 years.
* Obtain written informed consent.

Exclusion Criteria:

* Operation time less than 2 hours.
* Refusal to provide written informed consent.
* Cognitive impairment before surgery(mini-mental state examination, MMSE ≤ 26 or Montreal Cognitive Assessment, MoCA≤22).
* Allergic to the study drug.
* Body mass index ≤18 or ≥ 30 kg/m2.
* History of psychotropic drugs, anticholinergic drugs, antihistamine drug and dopaminergic drugs.
* History of traumatic brain injury or neurosurgery.
* Severe bradycardia (heart rate less than 40 beats per minute), sick sinus syndrome or second-to-third degree atrioventricular block.
* Severe liver dysfunction (Child-Pugh grade C) or renal failure (requiring kidney replacement therapy).
* The functional neurosurgery.

Primary outcomes:
measure: The incidence of postoperative delirium
timeFrame: postoperative 5 day
Secondary outcomes:
measure: Pain severity score
timeFrame: postoperative 5 day
measure: The quality of recovery
timeFrame: postoperative 1 day
measure: The quality of sleep
timeFrame: postoperative 3 day
measure: Cognitive function
timeFrame: 1 day before surgery and 5 days after surgery
measure: Psychological health state
timeFrame: 1 day before surgery and postoperative 5 day
measure: The intraoperative data
timeFrame: The surgery day
measure: Length of stay in ICU and hospital, hospitalization costs, and non-delirium complications.
timeFrame: postoperative 5 day
measure: 30-day all-cause mortality
timeFrame: postoperative 30 day
measure: The physiological status
timeFrame: 1 day before surgery
measure: Electroencephalogram changes
timeFrame: The surgery day
measure: Regional cerebral oxygen saturation changes
timeFrame: The surgery day
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tian Tan Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Tian Tan Hospital
name: Yuming Peng, MD,Ph.D
role: PRINCIPAL_INVESTIGATOR
References: