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Recruiting NCT05168280

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

No phase Interventional Dexmedetomidine Postoperative Delirium

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dexmedetomidine, 0.9% saline.
Who it may be relevant to
Registry conditions: Dexmedetomidine, Postoperative Delirium. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Drug Dexmedetomidine
    The 200ug dexmedetomidine will be diluted into a 50ml syringe and administered with 0.4ug/kg/h intraoperatively.
  • Drug 0.9% saline
    The 0.9% saline is administered with the same volume at the same speed as the other group.

Primary outcome measures

  • The incidence of postoperative delirium [Time frame: postoperative 5 day]
Secondary outcome measures (11)
  • Pain severity score [Time frame: postoperative 5 day]
  • The quality of recovery [Time frame: postoperative 1 day]
  • The quality of sleep [Time frame: postoperative 3 day]
  • Cognitive function [Time frame: 1 day before surgery and 5 days after surgery]
  • Psychological health state [Time frame: 1 day before surgery and postoperative 5 day]
  • The intraoperative data [Time frame: The surgery day]
  • Length of stay in ICU and hospital, hospitalization costs, and non-delirium complications. [Time frame: postoperative 5 day]
  • 30-day all-cause mortality [Time frame: postoperative 30 day]
  • The physiological status [Time frame: 1 day before surgery]
  • Electroencephalogram changes [Time frame: The surgery day]
  • Regional cerebral oxygen saturation changes [Time frame: The surgery day]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

China · 1 center
  • Beijing Tian Tan Hospital, Capital Medical University — Beijing

Publications

  • Cui Q, Ma T, Liu M, Shen Z, Li S, Zeng M, Liu X, Zhang L, Peng Y. Intraoperative infusion of dexmedetomidine for prevention of postoperative delirium in elderly patients undergoing craniotomy: a protocol of randomised clinical trial. BMJ Open. 2023 Jan 23;13(1):e063976. doi: 10.1136/bmjopen-2022-063976. PMID 36690404

Identifiers

NCT: NCT05168280 · 2021-12-05

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗