Intraoperative Infusion of Dexmedetomidine for Prevention of Postoperative Delirium in Elderly Patients
Primary Purpose
Dexmedetomidine, Postoperative Delirium
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Dexmedetomidine
0.9% saline
Sponsored by
About this trial
This is an interventional prevention trial for Dexmedetomidine
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing selective craniotomy.
- Age ≥65 years.
- Obtain written informed consent.
Exclusion Criteria:
- Operation time less than 2 hours.
- Refusal to provide written informed consent.
- Cognitive impairment before surgery(mini-mental state examination, MMSE ≤ 26 or Montreal Cognitive Assessment, MoCA≤22).
- Allergic to the study drug.
- Body mass index ≤18 or ≥ 30 kg/m2.
- History of psychotropic drugs, anticholinergic drugs, antihistamine drug and dopaminergic drugs.
- 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 liver dysfunction (Child-Pugh grade C) or renal failure (requiring kidney replacement therapy).
- The functional neurosurgery.
Sites / Locations
- Beijing Tian Tan Hospital, Capital Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
DEX group
Placebo group
Arm Description
The DEX group patients will be received dexmedetomidine intraoperatively.
The placebo group patients will be received 0.9% saline intraoperatively.
Outcomes
Primary Outcome Measures
The incidence of postoperative delirium
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
Pain severity score
The degree of surgical incision pain will be assessed at rest and on movement by Numerical Rating Scale (NRS). NRS ranges from 0 to 10, with the highest score indicating the worst pain.
The quality of recovery
The quality of recovery will be assessed with 15-item quality of recovery questionnaire (QoR-15). The QoR-15 measures cognitive function, physical activity, language and mood on a 150-point scale, with higher scores indicating better quality of recovery.
The quality of sleep
The quality of sleep will be assessed by the Richards Campbell sleep questionnaire (RCSQ).RCSQ is mainly used to evaluate the sleep quality of the previous night. The scale comprises five items: sleep depth, sleep latency, wake up times, relapse to sleep and overall sleep quality.The total score of the scale is the average of 5 items, and the lower the score, the better the sleep quality.
Cognitive function
Cognitive function will be assessed 1 day before surgery and 5 days after surgery using MMSE scale and Montreal Cognitive Assessment (MoCA) scale. MMSE includes seven items: time orientation, place orientation, immediate memory, attention and calculation, delayed memory, language and visual space.A total of 30 questions will be asked, 1 point for each correct answer, 0 point for a wrong answer or unknown answer and the total score range from 0 to 30. MoCA scale was widely identified that MoCA was superior to MMSE in the detection of mild cognitive impairment. Furthermore, the MoCA showed differences in cognitive profile even in those performing in the normal range on the MMSE and would appear to be a useful brief tool to assess cognition in those with mild cognitive impairment.
Psychological health state
Psychological health state will be assessed by Generalized Anxiety Disorder-7 (GAD-7) and Patient Health Questionnaire-9 (PHQ-9).There are 7 and 9 items to screen anxiety and depression, respectively. The point of each item is 3. The total points >4 will be regarded as anxiety and depression.
The intraoperative data
Intraoperative data include total dose of anesthetics, bispectral index scale value, and cardiovascular adverse events will be recorded and classified as hypotension (systolic blood pressure<95mmHg, or lower than 30% baseline), hypertension (systolic blood pressure ≥180 mmHg, or higher than 30% baseline), bradycardia (heart rate <40 beats /min), tachycardia (heart rate ≥ 100 beats /min) or hypoxemia (pulse oxygen saturation<90%).
Length of stay in ICU and hospital, hospitalization costs, and non-delirium complications.
Non-delirium complications include cardiac arrest, infection of the incision, sepsis, intracranial hematoma, severe intracranial edema (base on brain images), stroke, myocardial infarction, pulmonary infection and embolism.
30-day all-cause mortality
Postoperative 30-day all-cause mortality.
The physiological status
The physiological status of the patients will be assessed by Short-Form Mini-nutrition assessment (MNA-SF) and FRAIL scale.
Full Information
NCT ID
NCT05168280
First Posted
December 13, 2021
Last Updated
August 25, 2022
Sponsor
Beijing Tiantan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05168280
Brief Title
Intraoperative Infusion of Dexmedetomidine for Prevention of Postoperative Delirium in Elderly Patients
Official Title
Intraoperative Infusion of Dexmedetomidine for Prevention of Postoperative Delirium in Elderly Patients Undergoing Craniotomy: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 18, 2022 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Postoperative delirium (POD) is a common surgical complication. The incidence is 10% to 22% in neurological procedures, and advanced age is a risk factor for neurological procedures. Many studies have shown that dexmedetomidine(DEX) may reduce the incidence of delirium in non-cardiac surgery patients and elderly patients. However, there are few studies focus on the effect of DEX on POD in elderly patients undergoing neurosurgery. The purpose of this study was to investigate the effect of DEX on POD in in elderly patients undergoing craniotomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dexmedetomidine, Postoperative Delirium
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
420 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DEX group
Arm Type
Active Comparator
Arm Description
The DEX group patients will be received dexmedetomidine intraoperatively.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
The placebo group patients will be received 0.9% saline intraoperatively.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
The 200ug dexmedetomidine will be diluted into a 50ml syringe and administered with 0.4ug/kg/h intraoperatively.
Intervention Type
Drug
Intervention Name(s)
0.9% saline
Intervention Description
The 0.9% saline is administered with the same volume at the same speed as the other group.
Primary Outcome Measure Information:
Title
The incidence of postoperative delirium
Description
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.
Time Frame
postoperative 5 day
Secondary Outcome Measure Information:
Title
Pain severity score
Description
The degree of surgical incision pain will be assessed at rest and on movement by Numerical Rating Scale (NRS). NRS ranges from 0 to 10, with the highest score indicating the worst pain.
Time Frame
postoperative 5 day
Title
The quality of recovery
Description
The quality of recovery will be assessed with 15-item quality of recovery questionnaire (QoR-15). The QoR-15 measures cognitive function, physical activity, language and mood on a 150-point scale, with higher scores indicating better quality of recovery.
Time Frame
postoperative 1 day
Title
The quality of sleep
Description
The quality of sleep will be assessed by the Richards Campbell sleep questionnaire (RCSQ).RCSQ is mainly used to evaluate the sleep quality of the previous night. The scale comprises five items: sleep depth, sleep latency, wake up times, relapse to sleep and overall sleep quality.The total score of the scale is the average of 5 items, and the lower the score, the better the sleep quality.
Time Frame
postoperative 3 day
Title
Cognitive function
Description
Cognitive function will be assessed 1 day before surgery and 5 days after surgery using MMSE scale and Montreal Cognitive Assessment (MoCA) scale. MMSE includes seven items: time orientation, place orientation, immediate memory, attention and calculation, delayed memory, language and visual space.A total of 30 questions will be asked, 1 point for each correct answer, 0 point for a wrong answer or unknown answer and the total score range from 0 to 30. MoCA scale was widely identified that MoCA was superior to MMSE in the detection of mild cognitive impairment. Furthermore, the MoCA showed differences in cognitive profile even in those performing in the normal range on the MMSE and would appear to be a useful brief tool to assess cognition in those with mild cognitive impairment.
Time Frame
1 day before surgery and 5 days after surgery
Title
Psychological health state
Description
Psychological health state will be assessed by Generalized Anxiety Disorder-7 (GAD-7) and Patient Health Questionnaire-9 (PHQ-9).There are 7 and 9 items to screen anxiety and depression, respectively. The point of each item is 3. The total points >4 will be regarded as anxiety and depression.
Time Frame
1 day before surgery and postoperative 5 day
Title
The intraoperative data
Description
Intraoperative data include total dose of anesthetics, bispectral index scale value, and cardiovascular adverse events will be recorded and classified as hypotension (systolic blood pressure<95mmHg, or lower than 30% baseline), hypertension (systolic blood pressure ≥180 mmHg, or higher than 30% baseline), bradycardia (heart rate <40 beats /min), tachycardia (heart rate ≥ 100 beats /min) or hypoxemia (pulse oxygen saturation<90%).
Time Frame
The surgery day
Title
Length of stay in ICU and hospital, hospitalization costs, and non-delirium complications.
Description
Non-delirium complications include cardiac arrest, infection of the incision, sepsis, intracranial hematoma, severe intracranial edema (base on brain images), stroke, myocardial infarction, pulmonary infection and embolism.
Time Frame
postoperative 5 day
Title
30-day all-cause mortality
Description
Postoperative 30-day all-cause mortality.
Time Frame
postoperative 30 day
Title
The physiological status
Description
The physiological status of the patients will be assessed by Short-Form Mini-nutrition assessment (MNA-SF) and FRAIL scale.
Time Frame
1 day before surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing selective craniotomy.
Age ≥65 years.
Obtain written informed consent.
Exclusion Criteria:
Operation time less than 2 hours.
Refusal to provide written informed consent.
Cognitive impairment before surgery(mini-mental state examination, MMSE ≤ 26 or Montreal Cognitive Assessment, MoCA≤22).
Allergic to the study drug.
Body mass index ≤18 or ≥ 30 kg/m2.
History of psychotropic drugs, anticholinergic drugs, antihistamine drug and dopaminergic drugs.
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 liver dysfunction (Child-Pugh grade C) or renal failure (requiring kidney replacement therapy).
The functional neurosurgery.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuming Peng, MD,Ph.D
Phone
8610-59976658
Email
florapym766@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuming Peng, MD,Ph.D
Organizational Affiliation
Beijing Tian Tan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tian Tan Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100070
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuming Peng
Phone
8610-59976658
Email
florapym766@163.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Study protocol and de-identified individual participant data could be shared after 1 year after publication with the permission of principle investigator for reasonable usage.
IPD Sharing Time Frame
The data could be shared after 1 year after publication with the permission of principle investigator. The duration of the data sharing will be determined by principle investigator after publication.
IPD Sharing Access Criteria
Study protocol and de-identified individual participant data could be shared after 1 year after publication with the permission of principle investigator. Please email principle investigator if researchers wish to have the data.
Learn more about this trial
Intraoperative Infusion of Dexmedetomidine for Prevention of Postoperative Delirium in Elderly Patients
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