Effects of Preoperative Oral Carbohydrates Loading in Patients at High Risk of Postoperative Nausea and Vomiting Undergoing Spinal Surgery
1 other identifier
interventional
288
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2016
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 20, 2016
CompletedFirst Posted
Study publicly available on registry
June 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedJune 20, 2018
June 1, 2018
3.5 years
June 20, 2016
June 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
incidence of nausea and vomiting
48 hours
Secondary Outcomes (1)
severity of nausea
48 hours
Study Arms (2)
oral carbohydrate beverage group
EXPERIMENTALcontrol group
PLACEBO COMPARATORInterventions
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
Eligibility Criteria
You may qualify if:
- female patient between 20 and 65 of age with ASA physical status Ⅰ-Ⅱ
- patient scheduled for elective spine surgery
- no smoking history
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul, 03722, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2016
First Posted
June 22, 2016
Study Start
June 1, 2016
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
June 20, 2018
Record last verified: 2018-06