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

NCT02706522 | Completed DMC

• 1 other identifier: 3-2015-0317
• Study Type: interventional
• Target: 3
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Insulin Resistance; Inflammation; Delirium

Outcome Measures

Primary Outcomes (1)

• serum S-100β level

  Postoperative 1 hr

Study Arms (2)

Allocated to Carbohydrated group

EXPERIMENTAL

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.

Dietary Supplement: Allocated to Carbohydrated group

Allocated to Placebo group

PLACEBO COMPARATOR

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.

Dietary Supplement: Allocated to Placebo group

Interventions

Allocated to Carbohydrated group 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.

Also known as: No NPO

Allocated to Carbohydrated group

Allocated to Placebo group DIETARY_SUPPLEMENT

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

Also known as: flavored water

Allocated to Placebo group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients undergoing total hip replacement or total knee replacement surgery

You may not qualify if:

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

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

MeSH Terms

Conditions

Insulin Resistance; Inflammation; Delirium

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor MD

Study Record Dates

• First Submitted: March 2, 2016
• First Posted: March 11, 2016
• Study Start: October 24, 2016
• Primary Completion: November 15, 2016
• Study Completion: January 26, 2017
• Last Updated: August 4, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share