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Effect of Dexmedetomidine on Postoperative Delirium After Awake Craniotomies

Key facts

Who runs it
Beijing Tiantan Hospital
Where
China1 site in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
People taking part
210 people, planned
Started
31 Mar 2022
Planned end
31 Dec 2025
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Dexmedetomidine
  • 0.9% saline
Record updated
13 February 2025

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • Patients undergoing selective awake craniotomies
  • Age ≥18 years
  • Obtain written informed consent

Who cannot take part

  • 2.Preoperative psychotropic medication within one year
  • 1.Preoperative moderate and severe cognitive impairment (Montreal Cognitive Assessment, MoCA< 18)
  • 5.History of traumatic brain injury or neurosurgery
  • 6.Severe bradycardia (heart rate less than 40 beats per minute), sick sinus syndrome or second-to-third degree atrioventricular block
  • 3.BMI≤18 or ≥30 Kg/ m2
  • 4.Pregnant or lactating women
  • 7.Severe hepatic or renal dysfunction

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 complication, and the incidence of POD ranges from 10% to 60%. Previous studies suggested that frontal approach and tumor located at the temporal lobe were independent risk factors for POD after supratentorial tumor resections. Therefore, patients undergoing awake craniotomies are high-risk populations for POD. A lot of trials show that dexmedetomidine might help to reduce the incidence of delirium in patients undergoing non-cardiac surgery. However, the impact of dexmedetomidine (DEX) on POD for patients undergoing awake craniotomies remains unclear. The purpose of this study was to investigate the effect of DEX on POD in patients undergoing awake craniotomies.

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Effect of Dexmedetomidine on Postoperative Delirium in Patients Undergoing Awake Craniotomies: a Randomized Controlled Trial
Record updated
13 February 2025