Effect of Preoperative Oral Carbohydrates on Quality of Recovery

Phase 3

Completed

• Conditions: Evidence of Cholecystectomy
• Interventions: Dietary Supplement: Allocated to MN NPO group,; Dietary Supplement: Allocated to Carbohydrated group; Dietary Supplement: Allocated to Placebo group

• Registration Number: NCT02555020
• Lead Sponsor: Yonsei University

Brief Summary

Carbohydrate loading is an important component of enhanced recovery pathways. Preoperative carbohydrate treatments have been widely adopted as part of enhanced recovery after surgery (ERAS) or fast-track surgery protocols. Although fast-track surgery protocols have been widely investigated and have been shown to be associated with improved postoperative outcomes, some individual constituents of these protocols, including preoperative carbohydrate treatment, have not been subject to such robust analysis.To assess the effects of preoperative carbohydrate treatment, compared with placebo or preoperative fasting, on postoperative recovery and insulin resistance in adult patients undergoing elective surgery.

Detailed Description

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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-11
• Study First Submitted QC: 2015-09-18
• Study First Posted: 2015-09-21
• Primary Completion: 2016-12-22
• Study Completion: 2016-12-23
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-15
• Last Update Posted: 2017-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

Inclusion Criteria

1. ASA (I/II)
2. Laparoscopic cholecystectomy.
3. KAROFSKY PERFORMANCE SCALE >70,
4. No history of major operation

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Exclusion Criteria

1. DM patients
2. GE reflux Hx patients.
3. No- compliance,
4. Previous Abdominal Surgery History

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Allocated to MN NPO group,	Allocated to MN NPO group,	1. Patients was administered in hospital 2. Randomization 3. Patient was allocated to MN group 4. Patients were NPO from mid night (MN) to Surgery
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
Quality of Recovery score using the QoR-40 Questionnaire	We check the QoR-40 at POD1 after cholecystectomy , an expected average 3days	We check the QoR-40 Questionnaire at discharge day