Perioperative Dexmedetomidine on Postoperative Delirium in Patients With Brain Tumors

Capital Medical University

Status: Enrolling

Conditions: Postoperative Delirium

Treatments: Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT06164314

2023064

Details and patient eligibility

About

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

Full description

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.

Enrollment: 366 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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366 participants in 2 patient groups, including a placebo group

Dex group

Experimental group

Description:

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

Treatment:

Drug: Dexmedetomidine

Placebo group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Dexmedetomidine