ElderlyNCT04891458
Effect of Intraoperative Sedation on PND in Elderly Patients
A study testing Patients received lighter sedation with propofol after spinal anesthesia., Patients received heavier sedation with propofol after spinal anesthesia and Patients received lighter sedation with dexmedetomidine after spinal anesthesia in people with Elderly and Anesthesia, run by Hebei Medical University Third Hospital.
Trial summary
The aim of this study was to identify the effects of different depths of sedation and choices of sedative drugs on perioperative neurocognitive disorders in the elderly patients receiving hip surgery under spinal anesthesia. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Elderly, Anesthesia
- What is being tested?
- Patients received lighter sedation with propofol after spinal anesthesia., Patients received heavier sedation with propofol after spinal anesthesia and Patients received lighter sedation with dexmedetomidine after spinal anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2021to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Acquisition of informed consent,
- Patients with hip fracture surgery under spinal anesthesia,
- Grade I to III based on American Society of Anesthesiologists ASA classification,
- Age ≥65.
Who cannot join
- There was a history of cardiovascular and cerebrovascular adverse events in the past six months, including myocardial infarction, angina pectoris, severe arrhythmia, stroke or transient ischemic attack (TIA)
- Heart failure (NYHA III / IV and / or LVEF < 30%)
- Bradycardia
- Respiratory failure (need oxygen)
- Glasgow Coma Scale ≤ 14 points
- Severe hepatic and renal insufficiency (child Pugh grade B or C)
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- Preoperative cognitive impairment or sedative drugs (benzodiazepines, etc.).
- Adverse reactions such as allergy to dexmedetomidine or / or propofol
- Preoperative bilateral hip fracture or other trauma need simultaneous operation
- Contraindications of spinal anesthesia
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Intraoperative Sedation on Perioperative Neurocognitive Disorders in Elderly Patients
The aim of this study was to identify the effects of different depths of sedation and choices of sedative drugs on perioperative neurocognitive disorders in the elderly patients receiving hip surgery under spinal anesthesia.
Read the detailed description
PND is a complication of the central nervous system after anesthesia and surgery which is considered to be a common complication in elderly patients. Age is an independent risk factor for the occurrence of PND. Prolonged hospitalization, incapacity and long duration of PND aggravate the economic burden of individuals, families and society. The pathogenesis of PND is still unclear. Recent studies suggest that the blood-brain barrier (BBB) is damaged by surgery or anesthesia, which causes the activation of inflammatory factors such as TNF α and NF - κ B, and then leads to the decline of hippocampus cognitive function. In recent years, it has been found that dexmedetomidine can reduce the brain injury during ischemia-reperfusion and reduce the occurrence of PND. BDNF is a neurotrophin, which plays an important role in the growth, differentiation, synaptic plasticity, survival and repair of neurons. Studies have shown that the decrease of BDNF concentration is related to PND, which can be used as an index to evaluate brain injury and predict PND. S100 β protein is a specific low molecular calcium binding protein of nervous system which can be increased early after brain injury, so it can be used to reflect the severity and prognosis of brain injury and predict PND.In this randomized controlled trial, investigators will compare the incidence of PND in hip surgery with four intraoperative sedation regimens. After spinal anesthesia, the following sedation regimen will be used: (1) Intravenous infusion of propofol to make patients receive lighter sedation(modified observer's assessment of alertness/sedation score[MOAA/S],0-2) (2) Intravenous infusion of propofol to make patients receive heavier sedation(MOAA/S,3-5) (3)After a bolus of dexmedetomidine, intravenous infusion of dexmedetomidine to make patients receive lighter sedation(MOAA/S,0-2) (4) After a bolus of dexmedetomidine, intravenous infusion of dexmedetomidine to make patients receive heavier sedation(MOAA/S,3-5). 3ml venous blood samples were collected before anesthesia (T0), 1 h after operation (T1), 1 day after operation (T2) and 7 days after operation (T3). Plasma samples were collected after centrifugation and the concentrations of BDNF and S100 β were determined by ELISA. After 7days of surgery, PND is screened by CAM with a trained research assistant everyday, and CAM positive patients are judged by a qualified psychiatrist to meet DSM-V criteria until the patient is discharged. For patients with PND, the delirium rating scale (DRS) was used to assess the degree of delirium.
- Conditions
- Elderly, Anesthesia
- Being tested
- Patients received lighter sedation with propofol after spinal anesthesia., Patients received heavier sedation with propofol after spinal anesthesia, Patients received lighter sedation with dexmedetomidine after spinal anesthesia, Patients received heavier sedation with dexmedetomidine after spinal anesthesia.
- Keywords
- Anesthesia, Spinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients received lighter sedation with propofol after spinal anesthesia.Drug
MOAA/S 0-2.
Patients received heavier sedation with propofol after spinal anesthesiaDrug
MOAA/S 3-5.
Patients received lighter sedation with dexmedetomidine after spinal anesthesiaDrug
MOAA/S 0-2.
Patients received heavier sedation with dexmedetomidine after spinal anesthesia.Drug
MOAA/S 3-5.
| Study group | Role | What they receive |
|---|---|---|
| Patients received lighter sedation with propofol after spinal anesthesia | Experimental | Continuous infusion of propofol at a rate of 1.0-4.0mg/kg per hour until the end of surgery to achieve MOAA/S 0-2. Receives: Drug: Patients received lighter sedation with propofol after spinal anesthesia. |
| Patients received heavier sedation with propofol after spinal anesthesia | Experimental | Continuous infusion of propofol at a rate of 1.0-4.0mg/kg per hour until the end of surgery to achieve MOAA/S 3-5. Receives: Drug: Patients received heavier sedation with propofol after spinal anesthesia |
| Patients received lighter sedation with dexmedetomidine after spinal anesthesia. | Experimental | Continuous infusion of dexmedetomidine at a rate of 0.2-0.7 mcg/ kg per hour until the end of surgery to achieve MOAA/S 0-2. Receives: Drug: Patients received lighter sedation with dexmedetomidine after spinal anesthesia |
| Patients received heavier sedation with dexmedetomidine after spinal anesthesia. | Experimental | Continuous infusion of dexmedetomidine at a rate of 0.2-0.7 mcg/ kg per hour until the end of surgery to achieve MOAA/S 3-5. Receives: Drug: Patients received heavier sedation with dexmedetomidine after spinal anesthesia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative delirium
Postoperative delirium is assessed with the Confusion Assessment Method and in accordance with the the Diagnostic and Statistical Manual of Mental Disorders, 5th edition diagnostic criteria for delirium，each postoperative day until discharge.
Delirium severity is scored using the long Confusion Assessment Method Severity score.
Measured: 1 week
Change from Cognitive state in 1 week.
Cognitive state is measured with the Beijing version of Montreal Cognitive Assessment preoperatively，on the first day and the seventh day after surgery. A score of ≥26 is considered normal in Montreal Cognitive Assessment，with the maximum score of 30 points. The lower the score, the worse the cognitive status.
Measured: 1 week
Secondary outcomes (1)
Inflammatory biomarker level in blood
BDNF、S100 β 、NF-κB、TNF-α
Measured: before anesthesia (T0), 1 hour after operation (T1), 1 day after operation (T2) and 7 days after operation (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start1 Jul 2021 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shuang Zhao, PhD, Study chair, Third Hospital of Hebei Medical University Department of AnesthesiologyShuxing Zhu, M.D, Study director, Third Hospital of Hebei Medical University Department of AnesthesiologyXiuli Wang, PhD, Principal investigator, Third Hospital of Hebei Medical University Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04891458
- Sponsor's protocol ID
- IOSPND
- Status last verified
- May 2021
- First submitted
- 13 May 2021
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraoperative Sedation on Perioperative Neurocognitive Disorders in Elderly Patients
- ClinicalTrials.gov ID
- NCT04891458
- Acronym / sponsor ID
- IOSPND
- Conditions
- Elderly, Anesthesia
- Keywords
- Anesthesia, Spinal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Hebei Medical University Third HospitalUniversity, hospital or other
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 18 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to identify the effects of different depths of sedation and choices of sedative drugs on perioperative neurocognitive disorders in the elderly patients receiving hip surgery under spinal anesthesia.
Detailed description
PND is a complication of the central nervous system after anesthesia and surgery which is considered to be a common complication in elderly patients. Age is an independent risk factor for the occurrence of PND. Prolonged hospitalization, incapacity and long duration of PND aggravate the economic burden of individuals, families and society. The pathogenesis of PND is still unclear. Recent studies suggest that the blood-brain barrier (BBB) is damaged by surgery or anesthesia, which causes the activation of inflammatory factors such as TNF α and NF - κ B, and then leads to the decline of hippocampus cognitive function. In recent years, it has been found that dexmedetomidine can reduce the brain injury during ischemia-reperfusion and reduce the occurrence of PND. BDNF is a neurotrophin, which plays an important role in the growth, differentiation, synaptic plasticity, survival and repair of neurons. Studies have shown that the decrease of BDNF concentration is related to PND, which can be used as an index to evaluate brain injury and predict PND. S100 β protein is a specific low molecular calcium binding protein of nervous system which can be increased early after brain injury, so it can be used to reflect the severity and prognosis of brain injury and predict PND.In this randomized controlled trial, investigators will compare the incidence of PND in hip surgery with four intraoperative sedation regimens. After spinal anesthesia, the following sedation regimen will be used: (1) Intravenous infusion of propofol to make patients receive lighter sedation(modified observer's assessment of alertness/sedation score[MOAA/S],0-2) (2) Intravenous infusion of propofol to make patients receive heavier sedation(MOAA/S,3-5) (3)After a bolus of dexmedetomidine, intravenous infusion of dexmedetomidine to make patients receive lighter sedation(MOAA/S,0-2) (4) After a bolus of dexmedetomidine, intravenous infusion of dexmedetomidine to make patients receive heavier sedation(MOAA/S,3-5). 3ml venous blood samples were collected before anesthesia (T0), 1 h after operation (T1), 1 day after operation (T2) and 7 days after operation (T3). Plasma samples were collected after centrifugation and the concentrations of BDNF and S100 β were determined by ELISA. After 7days of surgery, PND is screened by CAM with a trained research assistant everyday, and CAM positive patients are judged by a qualified psychiatrist to meet DSM-V criteria until the patient is discharged. For patients with PND, the delirium rating scale (DRS) was used to assess the degree of delirium.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients received lighter sedation with propofol after spinal anesthesia | Experimental | Drug: Patients received lighter sedation with propofol after spinal anesthesia.Continuous infusion of propofol at a rate of 1.0-4.0mg/kg per hour until the end of surgery to achieve MOAA/S 0-2. |
| Patients received heavier sedation with propofol after spinal anesthesia | Experimental | Drug: Patients received heavier sedation with propofol after spinal anesthesiaContinuous infusion of propofol at a rate of 1.0-4.0mg/kg per hour until the end of surgery to achieve MOAA/S 3-5. |
| Patients received lighter sedation with dexmedetomidine after spinal anesthesia. | Experimental | Drug: Patients received lighter sedation with dexmedetomidine after spinal anesthesiaContinuous infusion of dexmedetomidine at a rate of 0.2-0.7 mcg/ kg per hour until the end of surgery to achieve MOAA/S 0-2. |
| Patients received heavier sedation with dexmedetomidine after spinal anesthesia. | Experimental | Drug: Patients received heavier sedation with dexmedetomidine after spinal anesthesia.Continuous infusion of dexmedetomidine at a rate of 0.2-0.7 mcg/ kg per hour until the end of surgery to achieve MOAA/S 3-5. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Acquisition of informed consent,
- Patients with hip fracture surgery under spinal anesthesia,
- Grade I to III based on American Society of Anesthesiologists ASA classification,
- Age ≥65.
Key exclusion criteria (10 listed)
- There was a history of cardiovascular and cerebrovascular adverse events in the past six months, including myocardial infarction, angina pectoris, severe arrhythmia, stroke or transient ischemic attack (TIA)
- Heart failure (NYHA III / IV and / or LVEF < 30%)
- Bradycardia
- Respiratory failure (need oxygen)
- Glasgow Coma Scale ≤ 14 points
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients received lighter sedation with propofol after spinal anesthesia.MOAA/S 0-2. | Drug | Patients received lighter sedation with propofol after spinal anesthesia |
| Patients received heavier sedation with propofol after spinal anesthesiaMOAA/S 3-5. | Drug | Patients received heavier sedation with propofol after spinal anesthesia |
| Patients received lighter sedation with dexmedetomidine after spinal anesthesiaMOAA/S 0-2. | Drug | Patients received lighter sedation with dexmedetomidine after spinal anesthesia. |
| Patients received heavier sedation with dexmedetomidine after spinal anesthesia.MOAA/S 3-5. | Drug | Patients received heavier sedation with dexmedetomidine after spinal anesthesia. |
Primary outcome
postoperative delirium
Time frame: 1 week
Postoperative delirium is assessed with the Confusion Assessment Method and in accordance with the the Diagnostic and Statistical Manual of Mental Disorders, 5th edition diagnostic criteria for delirium，each postoperative day until discharge. Delirium severity is scored using the long Confusion Assessment Method Severity score.
Change from Cognitive state in 1 week.
Time frame: 1 week
Cognitive state is measured with the Beijing version of Montreal Cognitive Assessment preoperatively，on the first day and the seventh day after surgery. A score of ≥26 is considered normal in Montreal Cognitive Assessment，with the maximum score of 30 points. The lower the score, the worse the cognitive status.
1 secondary outcome
Inflammatory biomarker level in blood
Time frame: before anesthesia (T0), 1 hour after operation (T1), 1 day after operation (T2) and 7 days after operation (T3)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shuang Zhao, PhD study chair
Third Hospital of Hebei Medical University Department of Anesthesiology
Shuxing Zhu, M.D study director
Third Hospital of Hebei Medical University Department of Anesthesiology
Xiuli Wang, PhD principal investigator
Third Hospital of Hebei Medical University Department of Anesthesiology
Questions about this trial
What is this clinical trial studying?
A study testing Patients received lighter sedation with propofol after spinal anesthesia., Patients received heavier sedation with propofol after spinal anesthesia and Patients received lighter sedation with dexmedetomidine after spinal anesthesia in people with Elderly and Anesthesia, run by Hebei Medical University Third Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shuang Zhao, PhD (13613210924 ext. +86, zhaoshuang810924@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative delirium (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2021.