Perioperative Dexmedetomidine on Postoperative Delirium in Patients With Brain Tumors

Effect of Perioperative Dexmedetomidine on Postoperative Delirium in Patients With Brain Tumors: a Randomized Placebo-controlled Trial

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

Study Overview

• Status: Recruiting
• Conditions: Postoperative Delirium
• Intervention / Treatment: Drug: Dexmedetomidine

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 366
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yuming Peng; Phone Number: 0086+18601076588; Email: florapym766@163.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Tiantan Hospital
    • Contact: Yuming Peng; Phone Number: 0086+18601076588; Email: florapym766@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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
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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
the severity of postoperative delirium	Using the Delirium Rating Scale-Revised -98 (DRS-R-98) to assess.There are 3 diagnostic items (0~2 or 0~3 points each) and 13 severity assessment items (0~3 points each), for a total of 46 points. The higher the score, the more severe the delirium.	the postoperative 5 days
the intensity of pain	Using numerical rating scale (NRS) for pain to assess, ranging from 0 to 10 points, with 10 representing the worst imaginable pain.	the postoperative 5 days
the quality of sleep	The Richards-Campbell Sleep Questionnaire (RCSQ) will be used to assess subjective sleep quality. The scale is composed of 5 items, including sleep depth, sleep latency, wake times, return to sleep and overall sleep quality, all of which are scored by 0 ~ 100mm visual simulation (1 mm=1 point). The total score of the scale is the average score of the 5 items, and the higher the score, the better the sleep quality.	the postoperative 5 days
safety outcomes	Safety outcomes includes the incidence of hypotension (systolic blood pressure below 95mmHg or below 30% of baseline), hypertension (systolic blood pressure above 180mmHg or 30% above baseline), bradycardia (heart rate less than 40 beats per minute), tachycardia (heart rate more than 100 beats per minute), delayed extubation (more than from the end of surgery to 2 hours after surgery, for the ICU patients (more than 4 hours),hypoxemia (SpO2<90%)	from the start of medicine infusion to 48 hours postoperatively

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Investigators: Principal Investigator: Yuming Peng, Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: November 12, 2023
• First Submitted That Met QC Criteria: December 1, 2023
• First Posted (Actual): December 11, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 12, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Emergence Delirium; Delirium; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Neurotransmitter Agents; Hypnotics and Sedatives; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Dexmedetomidine
• Other Study ID Numbers: 2023064

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No