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Dexmedetomidine for Prevention of Postoperative Delirium After Intracranial Operation for Brain Tumor (DEPOD)

Primary Purpose

Central Nervous System Diseases

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Dexmedetomidine
Normal saline
Sponsored by
Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Central Nervous System Diseases focused on measuring dexmedetomidine, delirium, postoperative, intracranial operation, prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  1. Admitted to the ICU after 22:00 PM;
  2. Medical records documented preoperative history of mental or cognitive disorders including schizophrenia, epilepsy, Parkinsonism, or dementia;
  3. Medical records documented inability to communicate in the preoperative period due to coma or language barrier;
  4. History of drug abuse of psychoactive and anesthetic drugs;
  5. 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%;
  6. Serious hepatic dysfunction (Child-Pugh class C);
  7. Severe renal dysfunction requiring renal replacement therapy before the surgery;
  8. Allergies to ingredients or components of 5-[(1S)-1-(2,3-dimethylphenyl)ethyl]-1H-imidazole (dexmedetomidine hydrochloride);
  9. American Society of Anesthesiologists (ASA) classification of IV to VI;
  10. Moribund condition with low likelihood of survival for more than 24 hours;
  11. Pregnancy or lactation women;
  12. Current enrolment in another clinical trial;
  13. Refuse to participate.

Sites / Locations

  • Intensive Care Unit, Beijing Tiantan Hospital, Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dexmedetomidine group

Normal saline group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The incidence of postoperative delirium
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).

Secondary Outcome Measures

The incidence of adverse events
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%)
The incidence of non-delirium complications
Include airway obstruction and apnea, respiratory failure, cardiac events, coma, epilepsy, cerebral hemorrhage or infarction, renal injury and infection
Length of stay in the ICU
Time of ICU discharge
Length of stay in hospital
Time of hospital discharge
The incidence of all-caused deaths after the operation
All of the deaths that occur after the study agent infusion

Full Information

First Posted
May 19, 2020
Last Updated
January 27, 2021
Sponsor
Capital Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04399343
Brief Title
Dexmedetomidine for Prevention of Postoperative Delirium After Intracranial Operation for Brain Tumor
Acronym
DEPOD
Official Title
Dexmedetomidine for Prevention of Postoperative Delirium in Patients After Intracranial Operation for Brain Tumor: a Multicenter Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Anticipated)
Primary Completion Date
August 1, 2021 (Anticipated)
Study Completion Date
October 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Nervous System Diseases
Keywords
dexmedetomidine, delirium, postoperative, intracranial operation, prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine group
Arm Type
Experimental
Arm Description
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.
Arm Title
Normal saline group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Dexmedetomidine hydrochloride
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
0.9% Sodium Chloride
Intervention Description
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.
Primary Outcome Measure Information:
Title
The incidence of postoperative delirium
Description
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).
Time Frame
From postoperative day 1 to day 5
Secondary Outcome Measure Information:
Title
The incidence of adverse events
Description
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%)
Time Frame
From the start of study agent infusion to postoperative day 1
Title
The incidence of non-delirium complications
Description
Include airway obstruction and apnea, respiratory failure, cardiac events, coma, epilepsy, cerebral hemorrhage or infarction, renal injury and infection
Time Frame
From the start of study agent infusion to postoperative day 28
Title
Length of stay in the ICU
Description
Time of ICU discharge
Time Frame
From the start of study agent infusion to postoperative day 28
Title
Length of stay in hospital
Description
Time of hospital discharge
Time Frame
From the start of study agent infusion to postoperative day 28
Title
The incidence of all-caused deaths after the operation
Description
All of the deaths that occur after the study agent infusion
Time Frame
From the start of study agent infusion to postoperative day 28
Other Pre-specified Outcome Measures:
Title
The number of patients with the use of sedatives and analgesics
Description
Include propofol, midazolam, opioids and nonsteroidal anti-inflammatory drugs
Time Frame
From the start of study agent infusion to postoperative day 1
Title
Pain intensity
Description
Assessed by the critical-care pain observation tool (CPOT) with a total score of 0-8. Higher scores mean a worsening of pain.
Time Frame
From the start of study agent infusion to postoperative day 1
Title
Subjective sleep quality
Description
Assessed by numerical rating scale (NRS) with a total score of 0-10. Higher scores mean a better sleep.
Time Frame
From the start of study agent infusion to postoperative day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jian-Xin Zhou, MD
Phone
8610 59978019
Email
zhoujx.cn@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xuan He, MD
Email
hexuan1204@icloud.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian-Xin Zhou, MD
Organizational Affiliation
Intensive Care Unit, Beijing Tiantan Hospital, Capital Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Intensive Care Unit, Beijing Tiantan Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100070
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian-Xin Zhou, MD
Phone
86-10-59976579
Email
zhoujx.cn@icloud.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33234648
Citation
He X, Cheng KM, Zhang L, Gu H, Qu X, Xu Y, Ma P, Zhou JX. Dexmedetomidine for the prevention of postoperative delirium in patients after intracranial operation for brain tumours (DEPOD study): a study protocol and statistical plan for a multicentre randomised controlled trial. BMJ Open. 2020 Nov 23;10(11):e040939. doi: 10.1136/bmjopen-2020-040939.
Results Reference
derived

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Dexmedetomidine for Prevention of Postoperative Delirium After Intracranial Operation for Brain Tumor

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