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/37743486Actively Recruiting
Led by Beijing Tiantan Hospital · Updated on 2025-02-13
210
Participants Needed
1
Research Sites
4 weeks
Total Duration
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
Effect of Dexmedetomidine on Postoperative Delirium After Awake Craniotomies
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
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
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
Total: 1 location
1
Beijing Tian Tan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100160
Actively Recruiting
Y
Yuming Peng, MD,Ph.D
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Muhan Li, Minying Liu, Qianyu Cui...
https://pubmed.ncbi.nlm.nih.gov/37743486