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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02809950
Enrollment
288
Registered
2016-06-22
Start date
2016-06-01
Completion date
2019-12-31
Last updated
2018-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Disease

Keywords

postoperative nausea and vomiting, oral carbohydrate beverage

Brief summary

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.

Interventions

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

OTHERcontrol group

NPO from midnight of the day before surgery

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
incidence of nausea and vomiting48 hours

Secondary

MeasureTime frameDescription
severity of nausea48 hours11-point numerical rating scale (0: no nausea \ 10: worst imaginable nausea)

Countries

South Korea

Contacts

Primary ContactJin Sun Cho, MD
chjs0214@yuhs.ac82-2-2227-0396

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026