RecruitingNot ApplicableNCT05168280

Intraoperative Infusion of Dexmedetomidine for Prevention of Postoperative Delirium in Elderly Patients

Intraoperative Infusion of Dexmedetomidine for Prevention of Postoperative Delirium in Elderly Patients Undergoing Craniotomy: a Randomized Clinical Trial


Sponsor

Beijing Tiantan Hospital

Enrollment

420 participants

Start Date

Jul 18, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 65 Years

Inclusion Criteria3

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

Exclusion Criteria10

  • 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.

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Interventions

DRUGDexmedetomidine

The 200ug dexmedetomidine will be diluted into a 50ml syringe and administered with 0.4ug/kg/h intraoperatively.

DRUG0.9% saline

The 0.9% saline is administered with the same volume at the same speed as the other group.


Locations(1)

Beijing Tian Tan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

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NCT05168280


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