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Dexmedetomidine Alleviates Postoperative Delirium After Brain Tumor Resections

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Capital Medical University

Status

Completed

Conditions

Dexmedetomidine
Postoperative Delirium

Treatments

Drug: Dexmedetomidine
Drug: 0.9% saline

Study type

Interventional

Funder types

Other

Identifiers

NCT04674241
ChiECRCT20200436

Details and patient eligibility

About

Postoperative delirium (POD) is a common complication, and the incidence rate is about 25% in non cardiac surgery. Previous studies have reported that the total incidence of neurological pod ranged from 10% to 22%. Dexmedetomidine (DEX) is an a-2 adrenergic agonist for sedation. This kind of drug has little effect on respiratory function, is easy to wake up and has analgesic effect. It is a commonly used perioperative adjuvant drug. However, for neurosurgical patients with brain tumors, the role of DEX in POD is not clear. The purpose of this study was to investigate the effect of DEX on POD in neurosurgical brain tumor surgery.

Enrollment

260 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients undergoing selective frontotemporal tumor resection.
  • Age ≥18 years.
  • Obtain written informed consent.

Exclusion criteria

  • Refusal to provide written informed consent.
  • Preoperative severe cognitive impairment (mini-mental state examination, MMSE ≤ 20).
  • Allergic to the study drug.
  • History of psychotropic drugs within past 30 days.
  • Pregnant or lactating women.
  • 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 hepatic or renal dysfunction.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

260 participants in 2 patient groups, including a placebo group

DEX group
Active Comparator group
Description:
The DEX group will receives dexmedetomidine intraoperative.
Treatment:
Drug: Dexmedetomidine
Placebo group
Placebo Comparator group
Description:
The placebo group will receives 0.9% saline intraoperative.
Treatment:
Drug: 0.9% saline

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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