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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-24

Study Completion Date

2017-01-26

Brief Summary

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This study is to evaluate the effects of preoperative carbohydrate intake on perioperative neuroinflammation and development of delirium.

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Detailed Description

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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.

Conditions

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Insulin Resistance Inflammation Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Allocated to Carbohydrated group

1. Patients was administered in hospital
2. Randomization
3. Patient was allocated to Carbohydrated group
4. 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.

Group Type EXPERIMENTAL

Allocated to Carbohydrated group

Intervention Type DIETARY_SUPPLEMENT

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.

Allocated to Placebo group

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

Group Type PLACEBO_COMPARATOR

Allocated to Placebo group

Intervention Type DIETARY_SUPPLEMENT

Patients received 400 mL of oral flavored water (Placebo) 12 hours before anesthesia and 400 mL 2 hours before

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Allocated to Placebo group

Patients received 400 mL of oral flavored water (Placebo) 12 hours before anesthesia and 400 mL 2 hours before

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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No NPO flavored water

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No