Perioperative Dexmedetomidine on Postoperative Delirium in Patients With Brain Tumors

Not Applicable

Recruiting

• Conditions: Postoperative Delirium
• Interventions: Drug: Dexmedetomidine

• Registration Number: NCT06164314
• Lead Sponsor: Beijing Tiantan Hospital

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

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 Timeline

• Study First Submitted: 2023-11-12
• Study First Submitted QC: 2023-12-01
• Study First Posted: 2023-12-11
• Study Start: 2024-01-25
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-17
• Primary Completion: 2026-09-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 366

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dex group	Dexmedetomidine	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 group	Dexmedetomidine	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.

Primary Outcome Measures

Name	Time	Method
the incidence of delirium postoperatively	the postoperative 5 days	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.

Secondary Outcome Measures

Name	Time	Method
the intensity of pain	the postoperative 5 days	Using numerical rating scale (NRS) for pain to assess, ranging from 0 to 10 points, with 10 representing the worst imaginable pain.
the quality of sleep	the postoperative 5 days	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 severity of postoperative delirium	the postoperative 5 days	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.
safety outcomes	from the start of medicine infusion to 48 hours postoperatively	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%)

Trial Locations

Locations (1)

Beijing Tiantan Hospital; 🇨🇳 Beijing, China