Effects of S-ketamine and Continuous Iliac Fascia Space Block on Perioperative Neurological Cognitive Impairment and Postoperative Rehabilitation in Elderly Patients With Hip Fracture

March 27, 2022 updated by: Yangtian Shuang, Yangzhou University
Elderly patients with hip fracture are older and have a high incidence of perioperative complications. the postoperative recovery of elderly patients with hip fracture is affected by hemodynamic instability and pain caused by fracture. S-ketamine is the S-isomer of ketamine. Compared with traditional ketamine, S-ketamine has stronger analgesic effect and fewer adverse reactions of nervous system. The parasympathetic effect of S-ketamine can antagonize the circulatory inhibition of propofol and make the hemodynamics more stable in elderly patients with hip fracture.Iliac fascial space block (fasciailiacacompartmentblock,FICB) mainly depends on local anesthetics spreading to the femoral nerve, lateral femoral cutaneous nerve and obturator nerve in the iliofascial space to achieve analgesia in its dominant area. Ultrasound-guided iliac fascial space block can effectively reduce the amount of anesthetics and has shorter puncture time and fewer complications. It can more effectively reduce the perioperative pain of elderly patients with hip fracture.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
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

With the advent of the aging society, the incidence of hip fracture in elderly patients is increasing year by year, and the incidence of perioperative neurological cognitive impairment (PND) is increasing year by year. PND refers to postoperative brain dysfunction in patients without mental disorders, including postoperative delirium POD and postoperative cognitive dysfunction POCD. PND is more common in clinic, especially in the elderly. The main feature of PND is the long-term decline and decline of cognitive function after operation. PND not only prolongs the length of stay of patients, interferes with postoperative treatment, but even increases mortality. The pathogenesis of PND is not clear, and it is affected by many factors. Studies have shown that keeping intraoperative blood pressure at baseline to 10% above baseline can significantly reduce the incidence of PND. In addition, pain is also an important factor leading to the occurrence of PND. S-ketamine is the S-isomer of ketamine. Compared with traditional ketamine, S-ketamine has stronger analgesic effect and fewer adverse reactions of nervous system. The parasympathetic effect of S-ketamine can antagonize the circulatory inhibition of propofol and make the hemodynamics more stable. Iliac fascial space block (fasciailiacacompartmentblock,FICB) mainly depends on local anesthetics spreading to the femoral nerve, lateral femoral cutaneous nerve and obturator nerve in the iliofascial space to achieve analgesia in its dominant area. Ultrasound-guided iliac fascial space block can effectively reduce the amount of anesthetics and has shorter puncture time and fewer complications. In this study, a randomized controlled trial was conducted to observe the clinical effects of S-ketamine and ultrasound-guided iliac fascia block combined with general anesthesia in elderly patients with hip fracture, and to evaluate their clinical value.

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.
108

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

Study Locations

  • China
      • Yangzhou, China
        • Recruiting
        • Affiliated Hospital of Yangzhou University
        • Contact:

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 to 85 years (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Clinical diagnosis of hip fracture

Aged 65 or above

ASA Ⅰ-Ⅲ

No mental and nervous system diseases

No pathological fractures, such as bone tumor, bone tuberculosis, osteomyelitis, etc

No puncture site infection

No hospital stay for more than 48 hours after operation

Exclusion Criteria:

Patients with severe cardiac, hepatic and renal dysfunction before operation

Long-term use of analgesics, sedatives and alcoholism

Patients with respiratory tract management difficulties (modified Ma's score is IV)

Previous neuropsychiatric diseases such as severe cerebrovascular, Alzheimer's disease, epilepsy and Parkinson's disease

Previous history of intracranial surgery or craniocerebral injury

Severe vision, hearing, language impairment or other reasons unable to communicate

Allergic or contraindicated to ropivacaine or non-steroidal anti-inflammatory drugs (NSAID)

Emergency surgery or trauma patients.

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: Drug group
S-ketamine 0.1mg/kg was injected intravenously during anesthesia induction and esmolamine 0.1mg/ (kg.h) was injected intravenously during anesthesia maintenance.S-Ketamine was put into the analgesia pump as an adjuvant for continuous analgesia until 2 days after operation.
Drug: S-Ketamine
S-Ketamine0.1mg/kg was injected intravenously during anesthesia induction and S-Ketamine0.1mg/ (kg.h) was injected intravenously during anesthesia maintenance.S-Ketamine was put into the analgesia pump as an adjuvant for continuous analgesia until 2 days after operation.
Other Names:
  • control group
Experimental: Device group
The hip fracture was diagnosed clinically on admission and ultrasound-guided iliofascial space block was performed after evaluation, and the analgesia lasted until 2 days after operation.
Device: Continuous iliac fascia space block
After admission, the iliac fascia space block and catheterization were performed under the guidance of ultrasound, and the analgesia was continued until two days after operation.
Other Names:
  • control group
Placebo Comparator: Normal saline group
normal saline 0.1ml/kg was injected intravenously during anesthesia induction and normal saline 0.1ml/ (kg.h) was injected intravenously during anesthesia maintenance.normal saline was put into the analgesia pump as an adjuvant for continuous analgesia until 2 days after operation.
Drug: Normal saline
Normal saline0.1ml/kg was injected intravenously during anesthesia induction and Normal saline0.1ml/ (kg.h) was injected intravenously during anesthesia maintenance.Normal saline was put into the analgesia pump as an adjuvant for continuous analgesia until 2 days after operation.

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
incidence of peioperative neurocognitive impairment
Time Frame: Perioperative period
incidence of peioperative neurocognitive impairment
Perioperative period

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.
Yangzhou University

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: jJianhong Sun, master, Yangzhou University

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.
March 26, 2022

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.
April 26, 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.
January 31, 2023

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).
March 1, 2022

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.
March 27, 2022

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.
March 31, 2022

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.
March 31, 2022

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.
March 27, 2022

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.
March 1, 2022

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.
  • YShuang

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.

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