Effect of Preoperative Oral Carbohydrates on Quality of Recovery (laparoscopy)

Yonsei University

Status and phase: Completed; Phase 3

Conditions: Evidence of Cholecystectomy

Treatments: Dietary Supplement: Allocated to MN NPO group,; Dietary Supplement: Allocated to Placebo group; Dietary Supplement: Allocated to Carbohydrated group

Study type: Interventional

Funder types: Other

Identifiers

NCT02555020

3-2015-0158

Details and patient eligibility

About

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.

Full 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.

Enrollment: 153 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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153 participants in 3 patient groups, including a placebo group

Allocated to MN NPO group,

Experimental group

Description:

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

Treatment:

Dietary Supplement: Allocated to MN NPO group,

Allocated to Placebo group

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Allocated to Placebo group

Allocated to Carbohydrated group

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Allocated to Carbohydrated group