Effect of Preoperative Oral Carbohydrates on Postoperative Insulin Resistance in Patients Undergoing OPCAB(Off- Pump Coronary Artery Bypass Surgery)

Not Applicable

Completed

• Conditions: Coronary Artery Occlusive Dissease
• Interventions: Dietary Supplement: carbohydrate beverage

• Registration Number: NCT02330263
• Lead Sponsor: Yonsei University

Brief Summary

Surgical stress creates a state of insulin resistance which has been related to increased postoperative complications. Fasting before surgery induces a catabolic state that contributes to the development of insulin resistance. The aim of this study is to evaluate the effect of preoperative oral carbohydrates on postoperative insulin resistance in patients undergoing OPCAB (off-pump coronary artery bypass surgery). Sixty patients, aged 20 to 79 years, scheduled for OPCAB will be divided into carbohydrate (n=30) and control (n=30) groups. Randomly selected patients of the carbohydrate group are given 400ml of 12.8 g/100 ml carbohydrate beverage in the evening before surgery and in the morning of the operation day (3 hours before their scheduled operation). In contrast, patients in the control group consume no food or drink after midnight before their surgery. The primary endpoints are postoperative insulin resistance measured by short insulin tolerance test.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-29
• Study First Submitted QC: 2014-12-30
• Study Start: 2015-01
• Study First Posted: 2015-01-01
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-15
• Last Update Posted: 2016-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• patients who are scheduled to undergo OPCAB

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Exclusion Criteria

• Subjects are ineligible if they have DM(Diabetes Mellitus),
• Gastroesophageal reflux disease or gastric emptying disorder,
• inflammatory bowel disease,
• previous treatment for intra-abdominal cancer,
• entered surgery more than 5 hours after ingestion of the morning carbohydrate beverage,
• cognitive dysfunction,
• disabling mental change disorder,
• are unable to communicate or speak Korean

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
carbohydrate group	carbohydrate beverage	Randomly selected patients of the carbohydrate group are given 400ml of 12.8 g/100 ml carbohydrate beverage in the evening before their surgery and in the morning of the operation day (3 hours before their scheduled operation).

Primary Outcome Measures

Name	Time	Method
postoperative insulin resistance	within 1 hour after surgery

Secondary Outcome Measures

Name	Time	Method
preoperative discomfort	24 hours	the preoperative discomfort measured by VAS (Visual Analog Scale)
perioperative hemodynamic effect	24 hours	perioperative hemodynamic effect measured by amount of used vasopressors and minimum mixed venous oxygen saturation
postoperative complications	24 hours	infection, Myocardiac infarction, Acute renal failure, re-operation, death, etc

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of