- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02809950
Effects of Preoperative Oral Carbohydrates Loading in Patients at High Risk of Postoperative Nausea and Vomiting Undergoing Spinal Surgery
June 19, 2018 updated by: Yonsei University
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
288
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jin Sun Cho, MD
- Phone Number: 82-2-2227-0396
- Email: chjs0214@yuhs.ac
Study Locations
-
-
-
Seoul, Korea, Republic of, 03722
- Recruiting
- Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
-
Contact:
- Jin Sun Cho, MD
- Phone Number: 82-2-2227-0396
- Email: chjs0214@yuhs.ac
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: control group
|
NPO from midnight of the day before surgery
|
Experimental: oral carbohydrate beverage group
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
incidence of nausea and vomiting
Time Frame: 48 hours
|
48 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
severity of nausea
Time Frame: 48 hours
|
11-point numerical rating scale (0: no nausea ~10: worst imaginable nausea)
|
48 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2016
Primary Completion (Anticipated)
December 1, 2019
Study Completion (Anticipated)
December 1, 2019
Study Registration Dates
First Submitted
June 20, 2016
First Submitted That Met QC Criteria
June 21, 2016
First Posted (Estimate)
June 22, 2016
Study Record Updates
Last Update Posted (Actual)
June 20, 2018
Last Update Submitted That Met QC Criteria
June 19, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4-2015-0984
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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