Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05195034

Effect of Dexmedetomidine on Postoperative Delirium in Patients Undergoing Awake Craniotomies: a Randomized Controlled Trial

Led by Beijing Tiantan Hospital · Updated on 2025-02-13

210

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Postoperative delirium (POD) is a common complication occurring in 10% to 60% of patients, especially those undergoing awake craniotomies for tumor removal in the brain's frontal or temporal lobes. This study aims to explore the effect of dexmedetomidine on reducing POD in patients undergoing these awake brain surgeries, as its impact in this specific group is still unclear despite findings in other types of non-cardiac surgeries. The research is led by Beijing Tiantan Hospital and involves a randomized controlled trial design. Participants are randomly assigned to one of two groups: one group receives dexmedetomidine through continuous infusion during surgery at a dose of 0.2 micrograms per kilogram per hour until the dura mater is closed, while the other group receives a placebo consisting of 0.9% saline administered at the same volume and rate. The study includes a quadruple masking method to ensure unbiased results. Throughout the study, participants will be monitored for the incidence of postoperative delirium over a five-day period following surgery. Researchers will collect data on delirium occurrence to evaluate the treatment effect. The total duration of participation may vary based on individual surgery and recovery timelines, with careful observation and safety monitoring conducted during the postoperative phase.

CONDITIONS

Brief Title

Effect of Dexmedetomidine on Postoperative Delirium After Awake Craniotomies

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing selective awake craniotomies
  • Age 18 years or older
  • Able to provide written informed consent
Not Eligible

You will not qualify if you...

  • Preoperative moderate or severe cognitive impairment (MoCA score less than 18)
  • Use of psychotropic medication within the past year
  • Body mass index less than 18 or greater than 30 kg/m2
  • Pregnant or breastfeeding women
  • History of traumatic brain injury or previous neurosurgery
  • Severe bradycardia (heart rate below 40 beats per minute), sick sinus syndrome, or advanced heart block
  • Severe liver or kidney dysfunction

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for screening and enrollment

Treatment

Duration - Duration of surgery (intraoperative period)

Participants receive either dexmedetomidine or saline infusion during awake craniotomy surgery until the end of dural closure.

1 intraoperative treatment session

Post-operative Follow-up

Duration - 5 days post-surgery

Participants are monitored for postoperative delirium and recovery for 5 days after surgery.

Daily visits or assessments for up to 5 days postoperatively

Trial Site Locations

Total: 1 location

1

Beijing Tian Tan Hospital, Capital Medical University

Beijing, Beijing Municipality, China, 100160

Actively Recruiting

Loading map...

Research Team

Y

Yuming Peng, MD,Ph.D

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

Similar Trials

A Multi-Modal Combination Intervention to Promote Cognitive ...

Critical Illness

Actively Recruiting

1 location

Molecular Biomarkers in Delirium and Dementia

Delirium

Actively Recruiting

1 location

Anticoagulation and Inflammation Monitoring in Patients Afte...

Heart Surgery

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Effect of dexmedetomidine on postoperative delirium in patients undergoing awake craniotomies: study protocol of a randomized controlled trial.

Muhan Li, Minying Liu, Qianyu Cui...

https://pubmed.ncbi.nlm.nih.gov/37743486