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

Not Applicable

Completed

• Conditions: Inflammation; Insulin Resistance; Delirium
• Interventions: Dietary Supplement: Allocated to Carbohydrated group; Dietary Supplement: Allocated to Placebo group

• Registration Number: NCT02706522
• Lead Sponsor: Gangnam Severance Hospital

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.

Study Timeline

• Study First Submitted: 2016-03-02
• Study First Submitted QC: 2016-03-07
• Study First Posted: 2016-03-11
• Study Start: 2016-10-24
• Primary Completion: 2016-11-15
• Study Completion: 2017-01-26
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-03
• Last Update Posted: 2017-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Allocated to Carbohydrated group	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.
Allocated to Placebo group	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.

Primary Outcome Measures

Name	Time	Method
serum S-100β level	Postoperative 1 hr