Effect of Intraoperative Sedation on PND in Elderly Patients

May 17, 2021 updated by: Hebei Medical University Third Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Acquisition of informed consent,
  2. Patients with hip fracture surgery under spinal anesthesia,
  3. Grade I to III based on American Society of Anesthesiologists ASA classification,
  4. Age ≥65.

Exclusion Criteria:

  1. 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)
  2. Heart failure (NYHA III / IV and / or LVEF < 30%)
  3. Bradycardia
  4. Respiratory failure (need oxygen)
  5. Glasgow Coma Scale ≤ 14 points
  6. Severe hepatic and renal insufficiency (child Pugh grade B or C)
  7. Preoperative cognitive impairment or sedative drugs (benzodiazepines, etc.).
  8. Adverse reactions such as allergy to dexmedetomidine or / or propofol
  9. Preoperative bilateral hip fracture or other trauma need simultaneous operation
  10. Contraindications of spinal anesthesia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Drug: Patients received lighter sedation with propofol after spinal anesthesia.
MOAA/S 0-2.
Experimental: Patients received heavier 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 3-5.
Drug: Patients received heavier sedation with propofol after spinal anesthesia
MOAA/S 3-5.
Experimental: Patients received lighter 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 0-2.
Drug: Patients received lighter sedation with dexmedetomidine after spinal anesthesia
MOAA/S 0-2.
Experimental: 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.
Drug: Patients received heavier sedation with dexmedetomidine after spinal anesthesia.
MOAA/S 3-5.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 week
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 week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
BDNF、S100 β 、NF-κB、TNF-α
before anesthesia (T0), 1 hour after operation (T1), 1 day after operation (T2) and 7 days after operation (T3)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hebei Medical University Third Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Shuang Zhao, PhD, Third Hospital of Hebei Medical University Department of Anesthesiology
  • Study Director: Shuxing Zhu, M.D, Third Hospital of Hebei Medical University Department of Anesthesiology
  • Principal Investigator: Xiuli Wang, PhD, Third Hospital of Hebei Medical University Department of Anesthesiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 18, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IOSPND

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings