- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04399343
Dexmedetomidine for Prevention of Postoperative Delirium After Intracranial Operation for Brain Tumor (DEPOD)
Dexmedetomidine for Prevention of Postoperative Delirium in Patients After Intracranial Operation for Brain Tumor: a Multicenter Randomized Controlled Trial
Postoperative delirium is common after major surgery, and is associated with adverse outcomes. Systematic reviews and meta-analyses of randomized controlled trials have shown that perioperative administration of dexmedetomidine may decrease the incidence of postoperative delirium in patients after either cardiac or non-cardiac surgery. However, neurosurgical patients are often excluded in clinical trials of postoperative delirium.
In this prospective, multicenter, randomized, double-blinded, and placebo-controlled trial with two parallel arms, ICU admitted adult patients after intracranial operation for brain tumor will be enrolled. Low-dose dexmedetomidine will be applied during the early postoperative phase. The investigators aim to evaluate the efficacy and safety of low-dose dexmedetomidine for prevention of postoperative delirium in this patient population. The primary hypothesis is that, compared to the placebo group, the prophylactic use of low-dose dexmedetomidine can decrease the incidence of postoperative delirium without significant adverse events in patients after intracranial operation for brain tumor.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Postoperative delirium is common after major surgery, and is associated with adverse outcomes. However, patients with neurological illness are usually excluded from previous researches. Recently, limited studies have shown that the incidence of postoperative delirium in neurosurgical patients is approximately 20%, which is comparable to the results in other major surgery. Potential associations between postoperative delirium and adverse outcomes have also been found in neurosurgical patients. These results indicate that early prevention of postoperative delirium should be employed in this population.
As a highly selective α2-adrenergic receptor agonist, dexmedetomidine has been investigated as a preventive agent for postoperative delirium. Systematic reviews and meta-analyses of randomized controlled trials have shown that perioperative administration of dexmedetomidine may decrease the incidence of postoperative delirium in patients after either cardiac or non-cardiac surgery. However, neurosurgical patients are often excluded in clinical trials of postoperative delirium.
In this prospective, multicenter, randomized, double-blinded, and placebo-controlled trial with two parallel arms, ICU admitted adult patients after intracranial operation for brain tumor will be enrolled. Low-dose dexmedetomidine will be applied during the early postoperative phase. The investigators aim to evaluate the efficacy and safety of low-dose dexmedetomidine for prevention of postoperative delirium in this patient population. The primary hypothesis is that, compared to the placebo group, the prophylactic use of low-dose dexmedetomidine can decrease the incidence of postoperative delirium without significant adverse events in patients after intracranial operation for brain tumor.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Jian-Xin Zhou, MD
- Phone Number: 8610 59978019
- Email: zhoujx.cn@gmail.com
Study Contact Backup
- Name: Xuan He, MD
- Email: hexuan1204@icloud.com
Study Locations
-
-
Beijing
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Beijing, Beijing, China, 100070
- Intensive Care Unit, Beijing Tiantan Hospital, Capital Medical University
-
Contact:
- Jian-Xin Zhou, MD
- Phone Number: 86-10-59976579
- Email: zhoujx.cn@icloud.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
The inclusion criteria are adult patients after elective intracranial operation for brain tumor under general anesthesia and who are admitted to the ICU directly from the operating room or postoperative care unit.
The exclusion criteria include:
- Admitted to the ICU after 22:00 PM;
- Medical records documented preoperative history of mental or cognitive disorders including schizophrenia, epilepsy, Parkinsonism, or dementia;
- Medical records documented inability to communicate in the preoperative period due to coma or language barrier;
- History of drug abuse of psychoactive and anesthetic drugs;
- Known preoperative severe sinus bradycardia (lower than 50 beats/min), sick sinus syndrome, second- or third-degree atrioventricular block, or left ventricular ejection fraction lower than 30%;
- Serious hepatic dysfunction (Child-Pugh class C);
- Severe renal dysfunction requiring renal replacement therapy before the surgery;
- Allergies to ingredients or components of 5-[(1S)-1-(2,3-dimethylphenyl)ethyl]-1H-imidazole (dexmedetomidine hydrochloride);
- American Society of Anesthesiologists (ASA) classification of IV to VI;
- Moribund condition with low likelihood of survival for more than 24 hours;
- Pregnancy or lactation women;
- Current enrolment in another clinical trial;
- Refuse to participate.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dexmedetomidine group
Continuously intravenous infusion of dexmedetomidine hydrochloride at a rate of 0.1 μg/kg/hour (0.025 ml/kg/hour) started immediately after enrollment until 08:00 AM on the postoperative day one.
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Dexmedetomidine hydrochloride (200 μg/2 ml) is diluted with normal saline to 50 ml and is continuously intravenous infused at a rate of 0.025 ml/kg/hour (dexmedetomidine 0.1 μg/kg/hour).
The intravenous infusion begins immediately after enrollment until 08:00 AM on the postoperative day one.
Other Names:
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Placebo Comparator: Normal saline group
Continuously intravenous infusion of normal saline at a rate of 0.025 ml/kg/hour started immediately after enrollment until 08:00 AM on the postoperative day one.
|
Normal saline is also diluted with normal saline to 50 ml and is continuously intravenous infused at a rate of 0.025 ml/kg/hour, which is the same with the dexmedetomidine group.
The intravenous infusion begins immediately after enrollment until 08:00 AM on the postoperative day one.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The incidence of postoperative delirium
Time Frame: From postoperative day 1 to day 5
|
Postoperative delirium is defined as delirium within 5 postoperative days, which is diagnosed by the Confusion Assessment Method for the ICU (CAM-ICU) evaluated twice daily (8:00-10:00 AM, and 18:00-20:00 PM).
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From postoperative day 1 to day 5
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The incidence of adverse events
Time Frame: From the start of study agent infusion to postoperative day 1
|
Include bradycardia (defined as heart rate lower than 55 beats/min), hypotension (defined as systolic blood pressure lower than 90 mmHg), and hypoxemia (defined as pulse oxygen saturation lower than 90%)
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From the start of study agent infusion to postoperative day 1
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The incidence of non-delirium complications
Time Frame: From the start of study agent infusion to postoperative day 28
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Include airway obstruction and apnea, respiratory failure, cardiac events, coma, epilepsy, cerebral hemorrhage or infarction, renal injury and infection
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From the start of study agent infusion to postoperative day 28
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Length of stay in the ICU
Time Frame: From the start of study agent infusion to postoperative day 28
|
Time of ICU discharge
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From the start of study agent infusion to postoperative day 28
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Length of stay in hospital
Time Frame: From the start of study agent infusion to postoperative day 28
|
Time of hospital discharge
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From the start of study agent infusion to postoperative day 28
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The incidence of all-caused deaths after the operation
Time Frame: From the start of study agent infusion to postoperative day 28
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All of the deaths that occur after the study agent infusion
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From the start of study agent infusion to postoperative day 28
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The number of patients with the use of sedatives and analgesics
Time Frame: From the start of study agent infusion to postoperative day 1
|
Include propofol, midazolam, opioids and nonsteroidal anti-inflammatory drugs
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From the start of study agent infusion to postoperative day 1
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Pain intensity
Time Frame: From the start of study agent infusion to postoperative day 1
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Assessed by the critical-care pain observation tool (CPOT) with a total score of 0-8.
Higher scores mean a worsening of pain.
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From the start of study agent infusion to postoperative day 1
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Subjective sleep quality
Time Frame: From the start of study agent infusion to postoperative day 1
|
Assessed by numerical rating scale (NRS) with a total score of 0-10.
Higher scores mean a better sleep.
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From the start of study agent infusion to postoperative day 1
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Neurologic Manifestations
- Confusion
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Delirium
- Nervous System Diseases
- Central Nervous System Diseases
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Hypnotics and Sedatives
- Dexmedetomidine
Other Study ID Numbers
- KY2019-091-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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