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A single-center, randomized, single-blind, placebo-controlled prophylactic study evaluating dexmedetomidine in patients with delirium after cerebrovascular intervention

A single-center, randomized, single-blind, placebo-controlled prophylactic study evaluating dexmedetomidine in patients with delirium after cerebrovascular intervention

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039854
Enrollment
Unknown
Registered
2020-11-12
Start date
2020-11-06
Completion date
Unknown
Last updated
2021-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

delirium after cerebrovascular intervention

Interventions

treatment group:Dexmedetomidine hydrochloride injection (1ml:100ug
1ug/kg loading dose) was added to 100mL saline solution for 10min, and then injected with a micropump at 0.5ug/kg/h.
control group:0.9% sodium chloride injection, the same dose of normal saline

Sponsors

Department of Anesthesiology, Shandong provincial Qianfoshan Hospital, the First Hospital Affiliated with Shandong First Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) After the patients have a full understanding of the purpose and significance of this trial, they voluntarily participate in this trial and sign the informed consent. 2) Type of operation: cerebral vascular stent implantation under general anesthesia, preoperative cerebral angiography showed > 70% stenosis, or = 30ml/min; e. Hemoglobin: >= 90g/L; f. Platelet count: >= 75.0 x 10^9g/L; g. Neutrophil count: >= 1.5 x 10^9g/L; 6) No mental disorder, normal consciousness and normal communication; 7) ASA grade I-II; 8) No contraindications to the use of dexmedetomidine.

Exclusion criteria

Exclusion criteria: 1) Preoperative history of cerebral ischemia with left sensory and motor abnormalities in one or both limbs; 2) Patients with possible adverse reactions to dexmedetomidine use, including bradycardia (heart rate = 160mmHg, and/or diastolic blood pressure >= 100mmHg), or hypotensive patients (systolic blood pressure upper limit of 2.5 times normal value of ALT and/or AST, > 1.5 times normal value of total bilirubin, and > 1.5 times normal value of serum creatinine); 12) Randomly assigned to use alpha 2 adrenergic agonists or antagonists during the first 14 days; 13) Patients who had used benzodiazepines, barbiturates and other sedatives in the previous 7 days (those whose elution period exceeded 5 half-lives could be included); 14) Persons with a history of drug abuse, drug abuse and alcohol abuse, in which alcohol abuse was defined as drinking more than 2 units of alcohol per day on average (1 unit =360ml beer or 45ml alcohol: 40% white wine or 150ml wine); 15) Allergic to dexmedetomidine, midazolam, fentanyl and other drug ingredients or components; 16) The investigator considers that there are any other conditions that are not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
the proportion of patients with delirium within 7 days of medication.;

Secondary

MeasureTime frame
Safety evaluation was required before and after administration. If AE appeared during the test, it was necessary to follow up to the end of AE, stabilize, return to the baseline level or lose follow-up.;

Countries

China

Contacts

Public ContactMing Hou

Department of Anesthesiology, Shandong Provincial Qianfoshan Hospital, the First Hospital Affiliated with Shandong First Medical University

13869183831@126.com+86 13869183831

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026