Effect of Preoperative Oral Carbohydrates on Quality of Recovery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Preoperative Oral Carbohydrates on Quality of Recovery: Randomized Controlled Trial

Conditions
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Evidence of Cholecystectomy

Intervention / Treatment
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* Dietary Supplement: Allocated to Carbohydrated group
* Dietary Supplement: Allocated to Placebo group
* Dietary Supplement: Allocated to MN NPO group,


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA (I/II) Laparoscopic cholecystectomy. KAROFSKY PERFORMANCE SCALE >70, No history of major operation Exclusion Criteria: DM patients GE reflux Hx patients. No- compliance, Previous Abdominal Surgery History

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Allocated to MN NPO group,<br>Patients was administered in hospital Randomization Patient was allocated to MN group Patients were NPO from mid night (MN) to Surgery | Dietary Supplement: Allocated to MN NPO group,<br>* Patients received NPO from MN.<br>|
| Placebo Comparator: Allocated to Placebo group<br>Patients was administered in hospital Randomization Patient was allocated to Placebo group Patients received 400 mL of water 12 hours before anesthesia and 400 mL 2 hours before anesthesia. | Dietary Supplement: Allocated to Placebo group<br>* Patients received 400 mL of oral free water (Placebo) 12 hours before anesthesia and 400 mL 2 hours before.<br>|
| Active Comparator: Allocated to Carbohydrated group<br>Patients was administered in hospital Randomization Patient was 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. | Dietary Supplement: Allocated to Carbohydrated group<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Recovery score using the QoR-40 Questionnaire | We check the QoR-40 Questionnaire at discharge day | We check the QoR-40 at POD1 after cholecystectomy , an expected average 3days |