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Dexmedetomidine Alleviates Postoperative Delirium After Brain Tumor Resections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04674241
Recruitment Status : Completed
First Posted : December 19, 2020
Last Update Posted : April 4, 2022
Sponsor:
Information provided by (Responsible Party):
Yuming Peng, Beijing Tiantan Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dexmedetomidine Postoperative Delirium Drug: Dexmedetomidine Drug: 0.9% saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Dexmedetomidine on Postoperative Delirium in Patients Undergoing Brain Tumor Resections: a Randomized Controlled Study
Actual Study Start Date : January 18, 2021
Actual Primary Completion Date : December 31, 2021
Actual Study Completion Date : January 28, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: DEX group
The DEX group will receives dexmedetomidine intraoperative.
Drug: Dexmedetomidine
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.

Placebo Comparator: Placebo group
The placebo group will receives 0.9% saline intraoperative.
Drug: 0.9% saline
0.9% saline is administered with the same volume at the same speed as the other group.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04674241


Locations
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China, Beijing,China
Beijing TianTan Hospital,Capital Medical University
Beijing, Beijing,China, China, 100070
China
PLA General Hospital
Beijing, China, 100853
Sponsors and Collaborators
Beijing Tiantan Hospital
Investigators
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Principal Investigator: Yu Ming Peng, MD,Ph.D Beijing Tian Tan Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yuming Peng, Deputy chief of Department of Anethesiology, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT04674241    
Other Study ID Numbers: ChiECRCT20200436
First Posted: December 19, 2020    Key Record Dates
Last Update Posted: April 4, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action