Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06164314

Perioperative Dexmedetomidine on Postoperative Delirium in Patients With Brain Tumors

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital

Beijing, China

Location status: Recruiting

Location contact

Yuming Peng

CONTACT

[email protected]

0086+18601076588

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. the incidence of delirium postoperatively

    Time frame: 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 outcomes

  1. the severity of postoperative delirium

    Time frame: 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.

  2. the intensity of pain

    Time frame: 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.

  3. the quality of sleep

    Time frame: 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.

  4. safety outcomes

    Time frame: 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%)

Study contacts

Contact information is provided by the study sponsor or research team.

Yuming Peng

CONTACT

[email protected]

0086+18601076588

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 11, 2023
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.