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Acupoint Stimulation Improve Cognitive Function in Elderly Patients (AICE)

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ClinicalTrials.gov Identifier: NCT03726073
Recruitment Status : Not yet recruiting
First Posted : October 31, 2018
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
Zhihong LU, Fourth Military Medical University

Brief Summary:
Postoperative cognitive dysfunction is with increased incidence in elderly patients. Previous studies have shown that acupuncture related techniques could induce protection against brain ischemia and improve outcome after cerebral diseases. In this study the effect of transcutaneous electrical acupoint stimulation on postoperative cognitive function will be evaluated.

Condition or disease Intervention/treatment Phase
Postoperative Complications Postoperative Delirium Device: electrodes Device: electrical stimulation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Masking Description: transcutaneous electrical acupoint stimulation is given by an investigator who is not involved in anesthesia and outcome assessment
Primary Purpose: Prevention
Official Title: Effect of Transcutaneous Electrical Acupoint Stimulation on Postoperative Cognitive Function in Elderly Patients
Estimated Study Start Date : December 10, 2018
Estimated Primary Completion Date : December 10, 2020
Estimated Study Completion Date : December 10, 2020

Arm Intervention/treatment
Experimental: acupoint stimulation
electrodes attached and electrical stimulation is given
Device: electrodes
electrodes are attached to acupoints Zusanli (ST36), Neiguan (PC6) and Hegu (LI4)

Device: electrical stimulation
electrodes are ligated to a stimulator and electrical stimulation is given

Sham Comparator: Control
electrodes attached but no electrical stimulation is given
Device: electrodes
electrodes are attached to acupoints Zusanli (ST36), Neiguan (PC6) and Hegu (LI4)




Primary Outcome Measures :
  1. Score of mini-mental state examination at 24 hours after surgery [ Time Frame: from end of surgery to 24 hours after surgery ]
  2. Score of mini-mental state examination at 72 hours after surgery [ Time Frame: from end of surgery to 72 hours after surgery ]

Secondary Outcome Measures :
  1. incidence of delirium during emergence [ Time Frame: from end of sevoflurane inhalation to 2 minutes after extubation, at an average of 20 minutes ]
  2. serum S100B level [ Time Frame: at the end of the surgery ]
  3. serum neuron-specific enolase level [ Time Frame: at the end of the surgery ]
  4. Serum brain-derived neurotrophic factor level [ Time Frame: at the end of the surgery ]
  5. serum tumor necrosis factor-α level [ Time Frame: at the end of the surgery ]
  6. serum interleukin-1β level [ Time Frame: at the end of the surgery ]
  7. serum Neutrophil gelatinase-associated lipocalin level [ Time Frame: at the end of the surgery ]


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Ages Eligible for Study:   65 Years to 100 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients scheduled for elective abdominal surgery under general anesthesia

Exclusion Criteria:

  • Age<65 years or >100 years
  • American Society of Anesthesiologists status >2
  • Existed neurologic or psychiatric disease
  • Existed or suspected abuse of drugs or alcohol
  • Mini-mental state examination score <24

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03726073


Contacts
Contact: Zhihong Lu 8613891975018 ext 8613891975018 deerlu23@163.com
Contact: Hailong Dong 8684775337 ext 8613891975018 hldong6@hotmail.com

Sponsors and Collaborators
Fourth Military Medical University
Investigators
Principal Investigator: Zhihong Lu Xijing Hospital

Publications:
Responsible Party: Zhihong LU, principle investigator, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT03726073     History of Changes
Other Study ID Numbers: XJH-A-20181001
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data of the study will be available for sharing after publishing, including data of the outcomes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: The data of the study will be available for sharing after publishing on peer-reviewed journals, and will be available for 5 years

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zhihong LU, Fourth Military Medical University:
cognitive function
elderly patients
acupoint stimulation

Additional relevant MeSH terms:
Delirium
Postoperative Complications
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Pathologic Processes