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Effects of Limb Remote Ischemic Preconditioning for Prevention of Delirium in Elderly Patients After Non-cardiac Surgery (LRIP-D)

Primary Purpose

Elderly Patients, Non-cardiac Surgery

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
limb remote ischemic preconditioning(LRIP)
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Elderly Patients focused on measuring elderly patients, non-cardiac surgery, ischemic preconditioning, delirium

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • elderly patients received elective non-cardiac surgery with general anesthesia
  • anticipated surgery time > 2 hours

Exclusion Criteria:

  • age < 65 years old
  • Acute coronary syndrome or myocardial infraction within 3 months
  • Chronic obstructive pulmonary emphysema
  • Serious hepatic dysfunction (Child-Pugh class C)
  • serious renal dysfunction (undergoing dialysis before surgery)
  • Ejection fraction less than 40%
  • Poor pulmonary function (PaO2 <60mmHg)
  • Preoperative history of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis
  • Inability to communicate in the preoperative period (coma, profound dementia, or language barrier)
  • Brain injury or neurosurgery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Limb RIPC

    Convention

    Arm Description

    The limb RIPC protocol was applied after anesthetic induction and before the start of surgery. The limb RIPC was induced by placing a blood pressure cuff on the left upper arm of patient for three inflating-deflating cycles: 5 min inflating to 200 mmHg followed by a 5 min reperfusion with deflating the cuff.

    Elderly patients undergoing non-cardiac surgery received no treatment after induction of anaesthesia

    Outcomes

    Primary Outcome Measures

    the incidence of delirium

    Secondary Outcome Measures

    Full Information

    First Posted
    January 19, 2017
    Last Updated
    January 19, 2017
    Sponsor
    Nanfang Hospital, Southern Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03028389
    Brief Title
    Effects of Limb Remote Ischemic Preconditioning for Prevention of Delirium in Elderly Patients After Non-cardiac Surgery
    Acronym
    LRIP-D
    Official Title
    Effects of Limb Remote Ischemic Preconditioning for Prevention of Delirium in Elderly Patients After Non-cardiac Surgery:a Randomised, Double-blind, Placebo-controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 1, 2017 (Anticipated)
    Primary Completion Date
    February 2017 (Anticipated)
    Study Completion Date
    February 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Nanfang Hospital, Southern Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To investigate whether limb remote ischemic preconditioning (LRIP) could safely decrease the incidence of delirium in elderly patients after non-cardiac surgery.
    Detailed Description
    Remote ischaemic preconditioning may confer the cytoprotection in critical organs. We hypothesized that limb remote ischemic preconditioning (RIPC) would safely decrease the incidence of delirium in elderly patients after non-cardiac surgery.The primary outcomes included the incidence of delirium in the first 7 days after surgery using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) scale.The quality of recovery over a 6-month period was evaluated as well.Secondary endpoints included length of stay in the hospital after surgery (from day of surgery to hospital discharge), occurrence of non-delirium postoperative complications, and all-cause 6-month mortality.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Elderly Patients, Non-cardiac Surgery
    Keywords
    elderly patients, non-cardiac surgery, ischemic preconditioning, delirium

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    611 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Limb RIPC
    Arm Type
    Experimental
    Arm Description
    The limb RIPC protocol was applied after anesthetic induction and before the start of surgery. The limb RIPC was induced by placing a blood pressure cuff on the left upper arm of patient for three inflating-deflating cycles: 5 min inflating to 200 mmHg followed by a 5 min reperfusion with deflating the cuff.
    Arm Title
    Convention
    Arm Type
    No Intervention
    Arm Description
    Elderly patients undergoing non-cardiac surgery received no treatment after induction of anaesthesia
    Intervention Type
    Procedure
    Intervention Name(s)
    limb remote ischemic preconditioning(LRIP)
    Other Intervention Name(s)
    LRIP
    Intervention Description
    LRIP consisted of three cycles of left upper limb ischemia induced by inflating a blood pressure cuff on the left upper arm to 200mmHg, with an intervening 5 minutes of reperfusion, during which time the cuff was deflated.
    Primary Outcome Measure Information:
    Title
    the incidence of delirium
    Time Frame
    in the first 7 days after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: elderly patients received elective non-cardiac surgery with general anesthesia anticipated surgery time > 2 hours Exclusion Criteria: age < 65 years old Acute coronary syndrome or myocardial infraction within 3 months Chronic obstructive pulmonary emphysema Serious hepatic dysfunction (Child-Pugh class C) serious renal dysfunction (undergoing dialysis before surgery) Ejection fraction less than 40% Poor pulmonary function (PaO2 <60mmHg) Preoperative history of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis Inability to communicate in the preoperative period (coma, profound dementia, or language barrier) Brain injury or neurosurgery
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jian Liu, MD
    Phone
    +86-15013228487
    Email
    launfyy@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ke-Xuan Liu, Ph.D
    Organizational Affiliation
    Nanfang Hospital, the Southern Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effects of Limb Remote Ischemic Preconditioning for Prevention of Delirium in Elderly Patients After Non-cardiac Surgery

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