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

NCT ID: NCT02330263

Last Updated: 2016-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-07-31

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.

Conditions

Coronary Artery Occlusive Dissease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

carbohydrate group

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).

Group Type: EXPERIMENTAL

carbohydrate beverage

Intervention Type: DIETARY_SUPPLEMENT

400ml of 12.8 g/100 ml carbohydrate beverage

control group

Patients in the control group consume no food or drink after midnight before surgery.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

carbohydrate beverage

400ml of 12.8 g/100 ml carbohydrate beverage

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• patients who are scheduled to undergo OPCAB

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, Seoul, South Korea

Countries

South Korea

References

Lee B, Soh S, Shim JK, Kim HY, Lee H, Kwak YL. Evaluation of preoperative oral carbohydrate administration on insulin resistance in off-pump coronary artery bypass patients: A randomised trial. Eur J Anaesthesiol. 2017 Nov;34(11):740-747. doi: 10.1097/EJA.0000000000000637.

Reference Type: DERIVED

PMID: 28437263 (View on PubMed)

Other Identifiers

4-2014-0908

Identifier Type: -

Identifier Source: org_study_id