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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02706522
• Other study ID #: 3-2015-0317
• Status: Completed
• Phase: N/A
• First received: March 2, 2016
• Last updated: August 3, 2017
• Start date: October 24, 2016
• Est. completion date: January 26, 2017

Study information

• Verified date: August 2017
• Source: Gangnam Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: January 26, 2017
• Est. primary completion date: November 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Inflammation
• Insulin Resistance

Intervention

Dietary Supplement:
• 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.
• Allocated to Placebo group
Patients received 400 mL of oral flavored water (Placebo) 12 hours before anesthesia and 400 mL 2 hours before

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum S-100ß level		Postoperative 1 hr