Perioperative Dexmedetomidine on Postoperative Delirium in Patients With Brain Tumors

Study Purpose

Neurosurgery is a risk factor for delirium. Dexmedetomidine might reduce delirium by reducing neuroinflammation, improving postoperative analgesia and sleep quality. The the primary hypothesis is that perioperative administration of dexmedetomidine can reduce the incidence of postoperative delirium

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Patients with temporal glioma scheduled for a elective craniotomy.

- Age ≥18 years.

- Obtain written informed consent.

Exclusion Criteria:

- Patients with severe preoperative cognitive impairment.

- History of traumatic brain injury or previous neurosurgery.

- History of psychotropic medications.

- Allergy to dexmedetomidine.

- Pregnant or lactating women.

- History of obstructive sleep apnoea syndrome.

- Severe bradycardia(heart rate <40 beats/min), sick sinus syndrome or second-to-third degree atrioventricular block.

- Severe hepatic dysfunction.

- Severe renal dysfunction

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06164314
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Beijing Tiantan Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Yuming Peng
Principal Investigator Affiliation	Beijing Tiantan Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Postoperative Delirium

Additional Details

The investigators will be required to attend the professional training before recruitment and strictly adhere to the study protocol. All the raw data will be recorded in the case report forms. Data will be entered doubly performed by two investigators and monitored securely in an electronic database with password protection at the medical center. The data base will be locked after all data have been cleaned. All the original fles will be maintained in storage for 5 years after completion of the study.

Arms & Interventions

Arms

Experimental: Dex group

Subjects assigned to Dex group will receive a continuous dexmedetomidine infusion (0.4 ug/kg/h) after anesthesia induction until dural closure, and then received an intravenous analgesia pump with dexmedetomidine(0.08ug/kg/h), sufentanil and antiemetic until 48 hours postoperatively

Placebo Comparator: Placebo group

Subjects in the Placebo group were given comparable volumes of normal saline during the surgery, and intravenous analgesia pump also contains sufentanil and antiemetic, but no dexmedetomidine used until 48 hours postoperatively.

Interventions

Drug: - Dexmedetomidine

In Dex group, dexmedetomidine will continue to be used during and after surgery, with a infusion of 0.4ug/kg/ h from anesthesia induction to dural closure, and then 0.08ug/kg/ h to 48 hours postoperatively.In placebo group, equivalent normal saline will be injected during operation, and the intravenous analgesia pump will not contain dexmedetomidine after operation

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Beijing Tiantan Hospital, Beijing, China

Status

Address

Beijing Tiantan Hospital

Beijing, ,

Site Contact

Yuming Peng

[email protected]

0086+18601076588

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