Perioperative Dexmedetomidine on Postoperative Delirium in Patients With Brain Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

366 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-25

Study Completion Date

2026-09-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Postoperative Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

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

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.

Group Type PLACEBO_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No