Perioperative Dexmedetomidine on Postoperative Delirium in Patients With Brain Tumors

NCT06164314 | Recruiting DMC

• 1 other identifier: 2023064
• Study Type: interventional
• Target: 366
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postoperative Delirium

Outcome Measures

Primary Outcomes (1)

• the incidence of delirium postoperatively

  Using the Confusion Assessment Method for Intensive Care Unit (CAM-ICU) for critical care patients, or the 3-min Diagnostic interview for Confusion Assessment Method (3D-CAM) for ward assessment,combined with the Richmond Agitation Sedation Scale (RASS). Delirium assessments will be only conducted in patients with RASS sedation score exceeding -4.The CAM-ICU and the 3D-CAM describes four main characteristics of delirium: acute altered mental state ,fluctuating level of consciousness, inattention, and confusion of thought. If both the first and second features are present, and both the third or fourth features are present, the patient is diagnosed with postoperative delirium.

  the postoperative 5 days

Secondary Outcomes (4)

• the severity of postoperative delirium

  the postoperative 5 days

• the intensity of pain

  the postoperative 5 days

• the quality of sleep

  the postoperative 5 days

• safety outcomes

  from the start of medicine infusion to 48 hours postoperatively

Study Arms (2)

Dex group

EXPERIMENTAL

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

Drug: Dexmedetomidine

Placebo group

PLACEBO COMPARATOR

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.

Drug: Dexmedetomidine

Interventions

Dexmedetomidine 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

Dex group; Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with temporal glioma scheduled for a elective craniotomy
• Age ≥18 years
• Obtain written informed consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, China

RECRUITING

Related Publications (1)

• Zeng M, Zheng M, Wang J, Li S, Ji N, Peng Y. Effect of perioperative dexmedetomidine on postoperative delirium in patients with brain tumours: a protocol of a randomised controlled trial. BMJ Open. 2024 Nov 7;14(11):e084380. doi: 10.1136/bmjopen-2024-084380.

  PMID: 39515867 DERIVED

MeSH Terms

Conditions

Emergence Delirium

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yuming Peng

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuming Peng

CONTACT

0086+18601076588; florapym766@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 12, 2023
• First Posted: December 11, 2023
• Study Start: January 25, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)