Skip to main content
OpenTrials
Completed

NCT Number: NCT04674241

Dexmedetomidine Alleviates Postoperative Delirium After Brain Tumor Resections

Postoperative delirium (POD) is a common complication, and the incidence rate is about 25% in non cardiac surgery. Previous studies have reported that the total incidence of neurological pod ranged from 10% to 22%. Dexmedetomidine (DEX) is an a-2 adrenergic agonist for sedation. This kind of drug has little effect on respiratory function, is easy to wake up and has analgesic effect. It is a commonly used perioperative adjuvant drug. However, for neurosurgical patients with brain tumors, the role of DEX in POD is not clear. The purpose of this study was to investigate the effect of DEX on POD in neurosurgical brain tumor surgery.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing TianTan Hospital,Capital Medical University, Beijing, Beijing,China, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergoing selective frontotemporal tumor resection.
  • Age ≥18 years.
  • Obtain written informed consent.

Exclusion criteria

  • Refusal to provide written informed consent.
  • Preoperative severe cognitive impairment (mini-mental state examination, MMSE ≤ 20).
  • Allergic to the study drug.
  • History of psychotropic drugs within past 30 days.
  • Pregnant or lactating women.
  • History of traumatic brain injury or neurosurgery.
  • Severe bradycardia (heart rate less than 40 beats per minute), sick sinus syndrome or second-to-third degree atrioventricular block.
  • Severe hepatic or renal dysfunction.

Treatment and study plan

Dexmedetomidine

Drug

Ten minutes after anesthesia induction and endotracheal intubation, patients assigned to dexmedetomidine group were given a loading dose of dexmedetomidine 0.6 μg/kg over 10 minutes, followed by continuous infusion at a rate of 0.4 μg/kg/h until the start of dural closure.

0.9% saline

Drug

0.9% saline is administered with the same volume at the same speed as the other group.

Primary outcomes

  1. The incidence of postoperative delirium

    Time frame: postoperative 5 day

    Postoperative delirium is assessed by the combination of the Richmond Anxiety Scale (RASS) and the Confusion assessment method for intensive care unit (CAM-ICU) or the 3-minute diagnostic interview for CAM (3D-CAM) as applicable.

    Delirium consists of four main characteristics: acute onset of a change in mental status or a fluctuating level of consciousness, inattention, disorganized thinking and an altered level of consciousness. The patient was diagnosed as delirious if both the first and second features were present, and either the third or fourth was present.

    In the ICU, the delirium assessment was performed in two steps. The arousal level was first assessed by RASS. If the patient was not responsive to verbal stimuli (i.e. RASS score ≤-4), the remaining delirium assessment was aborted, and the patient was recorded as comatose. When the RASS score was greater than or equal to 3, delirium was evaluated using the CAM-ICU. Patients in general ward were evaluated by 3D-CAM.

Secondary outcomes

  1. Pain score

    Time frame: within 5 days after surgery

    Numerical Rating Scales, ranging from 0 to 10 points, with 10 representing the worst imaginable pain.

  2. Sleep quality

    Time frame: within 3 days after surgery

    Quality of sleep was assessed by the Richards Campbell sleep questionnaire (RCSQ) and with a 0-100-mm visual analog scale, with higher scores indicating better sleep quality.

  3. Quality of recovery from surgery

    Time frame: 1 day after surgery

    Postoperative quality of recovery was assessed through the Quality of Recovery 15 item

  4. Intraoperative cardiovascular event.

    Time frame: From the study drug infusion to the end of surgery.

    Including: hypotension was defined as systolic blood pressure <95 mm Hg or less than 30% below baseline; hypertension was defined as systolic blood pressure > 180 mm Hg or more than 30% above baseline; bradycardia was defined by heart rate <40 bpm, and tachycardia was defined by heart rate >100 bpm.

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

Effect of Dexmedetomidine on Postoperative Delirium in Patients Undergoing Brain Tumor Resections: a Randomized Controlled Study

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Dec 19, 2020
Registry last updated
Apr 4, 2022

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.

Related clinical trials

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