Intraoperative Infusion of Dexmedetomidine for Prevention of Postoperative Delirium in Elderly Patients
Key facts
- Who runs it
- Beijing Tiantan Hospital
- Where
- China2 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 420 people enrolled
- Started
- 18 Jul 2022
- Ended
- 30 Jun 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Dexmedetomidine
- 0.9% saline
- Record updated
- 28 August 2026
Who can take part
- Age
- 65 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- Patients undergoing selective craniotomy
- Age ≥65 years
- Obtain written informed consent
Who cannot take part
- Cognitive impairment before surgery(mini-mental state examination, MMSE ≤ 26 or Montreal Cognitive Assessment, MoCA≤22)
- Allergic to the study drug
- 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)
- Operation time less than 2 hours
- Refusal to provide written informed consent
- Body mass index ≤18 or ≥ 30 kg/m2
- The functional neurosurgery
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- DEX groupExisting treatment, for comparison
The DEX group patients will be received dexmedetomidine intraoperatively.
Treatment: Dexmedetomidine
- Placebo groupPlacebo, for comparison
The placebo group patients will be received 0.9% saline intraoperatively.
Treatment: 0.9% saline
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Intraoperative Infusion of Dexmedetomidine for Prevention of Postoperative Delirium in Elderly Patients Undergoing Craniotomy: a Randomized Clinical Trial
- Record updated
- 28 August 2026