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Effect of Preoperative Oral Carbohydrates on Quality of Recovery

NCT ID: NCT02555020

Last Updated: 2017-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-12-23

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.

Conditions

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Evidence of Cholecystectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Allocated to MN NPO group,

Intervention Type DIETARY_SUPPLEMENT

Patients received NPO from MN.

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.

Group Type PLACEBO_COMPARATOR

Allocated to Placebo group

Intervention Type DIETARY_SUPPLEMENT

Patients received 400 mL of oral free water (Placebo) 12 hours before anesthesia and 400 mL 2 hours before.

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.

Group Type ACTIVE_COMPARATOR

Allocated to Carbohydrated group

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Allocated to Placebo group

Patients received 400 mL of oral free water (Placebo) 12 hours before anesthesia and 400 mL 2 hours before.

Intervention Type DIETARY_SUPPLEMENT

Allocated to MN NPO group,

Patients received NPO from MN.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Joon Seong Park

GangNam Severance Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Lee JS, Song Y, Kim JY, Park JS, Yoon DS. Effects of Preoperative Oral Carbohydrates on Quality of Recovery in Laparoscopic Cholecystectomy: A Randomized, Double Blind, Placebo-Controlled Trial. World J Surg. 2018 Oct;42(10):3150-3157. doi: 10.1007/s00268-018-4717-4.

Reference Type DERIVED
PMID: 29915988 (View on PubMed)

Other Identifiers

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3-2015-0158

Identifier Type: -

Identifier Source: org_study_id