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

NCT02330263 | Completed

• 1 other identifier: 4-2014-0908
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• postoperative insulin resistance

  within 1 hour after surgery

Secondary Outcomes (3)

• preoperative discomfort

  24 hours

• perioperative hemodynamic effect

  24 hours

• postoperative complications

  24 hours

Study Arms (2)

carbohydrate group

EXPERIMENTAL

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).

Dietary Supplement: carbohydrate beverage

control group

NO INTERVENTION

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

Interventions

carbohydrate beverage DIETARY_SUPPLEMENT

400ml of 12.8 g/100 ml carbohydrate beverage

carbohydrate group

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who are scheduled to undergo OPCAB

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, Seoul, 120-752, South Korea

Location

Related Publications (1)

• 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.

  PMID: 28437263 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2014
• First Posted: January 1, 2015
• Study Start: January 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: August 17, 2016

Record last verified: 2016-08

Locations

KR (1)