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Effect of Oral Carbohydrate on Serum S-100β Protein and Development of Postoperative Delirium in Elderly Patients

Primary Purpose

Insulin Resistance, Inflammation, Delirium

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Allocated to Carbohydrated group
Allocated to Placebo group
Sponsored by
Gangnam Severance Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Insulin Resistance

Eligibility Criteria

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

Inclusion Criteria:

  • Patients undergoing total hip replacement or total knee replacement surgery

Exclusion Criteria:

  • Diabetes
  • Dementia
  • Gastro-esophageal reflux
  • Upper gastrointestinal motility disorder
  • Inflammatory bowel disease
  • Intraperitoneal malignancy history
  • Inability to perform cognitive function test

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Allocated to Carbohydrated group

    Allocated to Placebo group

    Arm Description

    Patients was administered in hospital Randomization Patient was allocated to Carbohydrated group Patients received 400 mL of oral isotonic glucose (No NPO®, Daesang, Korea) 12 hours before anesthesia and 400 mL 2 hours before. CHL composition was standard: 12.5 g of carbohydrate per 100 mL, 12% monosaccharide, 12% disaccharide, 76% polysaccharide, 250 mOsm/kg and 50 kcal.

    Patients was administered in hospital Randomization Patient was allocated to Placebo group Patients received 400 mL of water 12 hours before anesthesia and 400 mL 2 hours before anesthesia.

    Outcomes

    Primary Outcome Measures

    serum S-100β level

    Secondary Outcome Measures

    Full Information

    First Posted
    March 2, 2016
    Last Updated
    August 3, 2017
    Sponsor
    Gangnam Severance Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02706522
    Brief Title
    Effect of Oral Carbohydrate on Serum S-100β Protein and Development of Postoperative Delirium in Elderly Patients
    Official Title
    Effect of Oral Carbohydrate on Serum S-100β Protein and Development of Postoperative Delirium in Elderly Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 24, 2016 (Actual)
    Primary Completion Date
    November 15, 2016 (Actual)
    Study Completion Date
    January 26, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Gangnam Severance Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study is to evaluate the effects of preoperative carbohydrate intake on perioperative neuroinflammation and development of delirium.
    Detailed Description
    Perioperative insulin resistance may primarily contribute to development of postoperative delirium in high risk patients. Preoperative administration of oral carbohydrate reduces insulin resistance. The investigators aimed to investigate the influence of carbohydrate loading on the serum level of S-100β, a surrogate marker of delirium, and the incidence of postoperative delirium in elderly patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Insulin Resistance, Inflammation, Delirium

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    3 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Allocated to Carbohydrated group
    Arm Type
    Experimental
    Arm Description
    Patients was administered in hospital Randomization Patient was allocated to Carbohydrated group Patients received 400 mL of oral isotonic glucose (No NPO®, Daesang, Korea) 12 hours before anesthesia and 400 mL 2 hours before. CHL composition was standard: 12.5 g of carbohydrate per 100 mL, 12% monosaccharide, 12% disaccharide, 76% polysaccharide, 250 mOsm/kg and 50 kcal.
    Arm Title
    Allocated to Placebo group
    Arm Type
    Placebo Comparator
    Arm Description
    Patients was administered in hospital Randomization Patient was allocated to Placebo group Patients received 400 mL of water 12 hours before anesthesia and 400 mL 2 hours before anesthesia.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Allocated to Carbohydrated group
    Other Intervention Name(s)
    No NPO
    Intervention Description
    Patients received 400 mL of oral isotonic glucose (No NPO®, Daesang, Korea) 12 hours before anesthesia and 400 mL 2 hours before. CHL composition was standard: 12.5 g of carbohydrate per 100 mL, 12% monosaccharide, 12% disaccharide, 76% polysaccharide, 250 mOsm/kg and 50 kcal.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Allocated to Placebo group
    Other Intervention Name(s)
    flavored water
    Intervention Description
    Patients received 400 mL of oral flavored water (Placebo) 12 hours before anesthesia and 400 mL 2 hours before
    Primary Outcome Measure Information:
    Title
    serum S-100β level
    Time Frame
    Postoperative 1 hr

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients undergoing total hip replacement or total knee replacement surgery Exclusion Criteria: Diabetes Dementia Gastro-esophageal reflux Upper gastrointestinal motility disorder Inflammatory bowel disease Intraperitoneal malignancy history Inability to perform cognitive function test

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effect of Oral Carbohydrate on Serum S-100β Protein and Development of Postoperative Delirium in Elderly Patients

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