Effects of Preoperative Oral Carbohydrates Loading in Patients at High Risk of Postoperative Nausea and Vomiting Undergoing Spinal Surgery

NCT ID: NCT02809950

Last Updated: 2018-06-20

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

288 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-01

Study Completion Date

2019-12-31

Brief Summary

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Many patients receiving opioid based analgesia after spinal surgery experience postoperative nausea and vomiting (PONV) despite prophylaxis and treatment with antiemetic agents. Dehydration caused by fasting prior to surgery is associated with the development of PONV. The aim of this study is to investigate the effect of oral carbohydrates loading prior to surgery in patients at high risk of PONV undergoing spinal surgery.

Detailed Description

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Conditions

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Spinal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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oral carbohydrate beverage group

Group Type EXPERIMENTAL

oral carbohydrate beverage

Intervention Type OTHER

oral carbohydrate beverage (12.8% carbohydrates, 50 kcal/100ml, 290 mOsm/kg, NO-NPO®, Daesang WelLife Co., Ltd., Korea) 400ml in the evening of the day before surgery and at 6 am on the day of surgery, respectively

control group

Group Type PLACEBO_COMPARATOR

control group

Intervention Type OTHER

NPO from midnight of the day before surgery

Interventions

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oral carbohydrate beverage

oral carbohydrate beverage (12.8% carbohydrates, 50 kcal/100ml, 290 mOsm/kg, NO-NPO®, Daesang WelLife Co., Ltd., Korea) 400ml in the evening of the day before surgery and at 6 am on the day of surgery, respectively

Intervention Type OTHER

control group

NPO from midnight of the day before surgery

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* female patient between 20 and 65 of age with ASA physical status Ⅰ-Ⅱ
* patient scheduled for elective spine surgery
* no smoking history

Exclusion Criteria

* hepatorenal disease
* BMI \> 35 kg/m2
* gastrointestinal disease
* vomiting within 24h
* administration of antiemetics or opioids within 24 h prior to surgery
* pregnant
* problem with communication
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 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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Responsibility Role SPONSOR

Locations

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Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jin Sun Cho, MD

Role: CONTACT

82-2-2227-0396

Facility Contacts

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Jin Sun Cho, MD

Role: primary

82-2-2227-0396

Other Identifiers

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4-2015-0984

Identifier Type: -

Identifier Source: org_study_id

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