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Impact Dexmedetomidine on Postoperative Delirium in Patients After Intracranial Operation for Brain Tumor

Primary Purpose

Central Nervous System Diseases

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

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • age under 18 years;
  • 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 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 defined as Child-Pugh class C;
  • severe renal dysfunction requiring renal replacement therapy before the surgery;
  • allergies to ingredients or components of dexmedetomidine hydrochloride;
  • American Society of Anesthesiologists classification of IV to VI;
  • moribund condition with low likelihood of survival for more than 24 hours;
  • pregnancy or lactation women;
  • current enrollment in another clinical trial;
  • refusal to participate.

Sites / Locations

  • ICU, 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

Incidence of study agent interruption during the study
Predicted adverse events in the present study included bradycardia (defined as heart rate lower than 50 beats/min), hypotension (defined as systolic blood pressure lower than 90 mmHg), tachycardia (defined as heart rate greater than 100 beats/min), hypertension (defined as systolic blood pressure greater than 160 mmHg) and hypoxemia (defined as pulse oxygen saturation lower than 90%). The treatment of adverse events was determined by the responsible attending ICU physicians, who could stop the study agent infusion when the treatment failure or other conditions deemed necessary.

Secondary Outcome Measures

Time from the end of operation to randomization
Time from the end of operation to randomization
Duration of study agent infusion
Duration of study agent infusion
Incidence of adverse events from the start of study agent infusion until 24 hours or until ICU discharge
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%)
Non-delirium complications
Include airway obstruction and apnea, respiratory failure, cardiac events, coma, epilepsy, cerebral hemorrhage or infarction, renal injury and infection

Full Information

First Posted
July 28, 2020
Last Updated
January 10, 2021
Sponsor
Capital Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04494828
Brief Title
Impact Dexmedetomidine on Postoperative Delirium in Patients After Intracranial Operation for Brain Tumor
Official Title
Impact of Prophylactic Use of Dexmedetomidine on Postoperative Delirium in Patients After Intracranial Operation for Brain Tumor: a Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
August 10, 2020 (Actual)
Primary Completion Date
December 12, 2020 (Actual)
Study Completion Date
December 21, 2020 (Actual)

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 one of the most common serious complications after major surgery and is associated with undesirable consequences. Prevention of postoperative delirium is recommended in the clinical guidelines and consensus statements. Dexmedetomidine, a highly selective α2-adrenergic receptor agonist, has been investigated as a pharmacological intervention to prevent postoperative delirium. Several randomized controlled trials have shown that prophylactic use of low-dose dexmedetomidine may decrease the incidence of postoperative delirium in patients after cardiac and non-cardiac operations. However, neurosurgical patients are often excluded from previous studies due to potential consciousness and cognition impairment. The investigators design this pilot study aiming to clarify the feasibility and safety of use of low-dose dexmedetomidine for prevention of postoperative delirium in patients after intracranial operation for brain tumor.
Detailed Description
Postoperative delirium is one of the most common serious complications after major surgery and is associated with undesirable consequences. Prevention of postoperative delirium is recommended in the clinical guidelines and consensus statements. Dexmedetomidine, a highly selective α2-adrenergic receptor agonist, has been investigated as a pharmacological intervention to prevent postoperative delirium. Several randomized controlled trials have shown that prophylactic use of low-dose dexmedetomidine (0.1 ug/kg/hour without loading infusion) may decrease the incidence of postoperative delirium in patients after cardiac and non-cardiac operations. However, neurosurgical patients are often excluded from previous studies due to potential consciousness and cognition impairment. The investigators design this pilot randomized controlled trial aiming to clarify the feasibility and safety of use of low-dose dexmedetomidine for prevention of postoperative delirium 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
delirium, postoperative, dexmedetomidine, intracranial operation, prevention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

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 group
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
Incidence of study agent interruption during the study
Description
Predicted adverse events in the present study included bradycardia (defined as heart rate lower than 50 beats/min), hypotension (defined as systolic blood pressure lower than 90 mmHg), tachycardia (defined as heart rate greater than 100 beats/min), hypertension (defined as systolic blood pressure greater than 160 mmHg) and hypoxemia (defined as pulse oxygen saturation lower than 90%). The treatment of adverse events was determined by the responsible attending ICU physicians, who could stop the study agent infusion when the treatment failure or other conditions deemed necessary.
Time Frame
From the start of study agent infusion to postoperative day 1
Secondary Outcome Measure Information:
Title
Time from the end of operation to randomization
Description
Time from the end of operation to randomization
Time Frame
From the end of operation until the randomization, assessed up to 24 hours
Title
Duration of study agent infusion
Description
Duration of study agent infusion
Time Frame
From the start of study agent infusion to postoperative day 1
Title
Incidence of adverse events from the start of study agent infusion until 24 hours or until ICU discharge
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: age under 18 years; 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 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 defined as Child-Pugh class C; severe renal dysfunction requiring renal replacement therapy before the surgery; allergies to ingredients or components of dexmedetomidine hydrochloride; American Society of Anesthesiologists classification of IV to VI; moribund condition with low likelihood of survival for more than 24 hours; pregnancy or lactation women; current enrollment in another clinical trial; refusal to participate.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian-Xin Zhou, MD
Organizational Affiliation
Capital Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
ICU, Beijing Tiantan Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34863109
Citation
He X, Cheng KM, Duan YQ, Xu SS, Gao HR, Miao MY, Li HL, Chen K, Yang YL, Zhang L, Gu HQ, Zhou JX. Feasibility of low-dose dexmedetomidine for prevention of postoperative delirium after intracranial operations: a pilot randomized controlled trial. BMC Neurol. 2021 Dec 4;21(1):472. doi: 10.1186/s12883-021-02506-z.
Results Reference
derived

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Impact Dexmedetomidine on Postoperative Delirium in Patients After Intracranial Operation for Brain Tumor

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