Spinal DiseasePhase 4NCT02809950
Effects of Preoperative Oral Carbohydrates Loading in Patients at High Risk of Postoperative Nausea and Vomiting Undergoing Spinal Surgery
A Phase 4 study testing oral carbohydrate beverage in people with Spinal Disease, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Spinal Disease
- What is being tested?
- oral carbohydrate beverage
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 288 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2016to Dec 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female patient between 20 and 65 of age with ASA physical status Ⅰ-Ⅱ
- patient scheduled for elective spine surgery
- no smoking history
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul, 03722
Jin Sun Cho, MD, 82-2-2227-0396, chjs0214@yuhs.ac
About this study
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.
- Conditions
- Spinal Disease
- Being tested
- oral carbohydrate beverage, control group
- Keywords
- postoperative nausea and vomiting, oral carbohydrate beverage
- Medical subject headings
- Spinal Diseases, Postoperative Nausea and Vomiting, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral carbohydrate beverageOther
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 groupOther
NPO from midnight of the day before surgery
| Study group | Role | What they receive |
|---|---|---|
| oral carbohydrate beverage group | Experimental | Not described Receives: Other: oral carbohydrate beverage |
| control group | Placebo comparator | Not described Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of nausea and vomiting
Measured: 48 hours
Secondary outcomes (1)
severity of nausea
11-point numerical rating scale (0: no nausea ~10: worst imaginable nausea)
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study start1 Jun 2016
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02809950
- Sponsor's protocol ID
- 4-2015-0984
- Status last verified
- Jun 2018
- First submitted
- 20 Jun 2016
- Last updated
- 20 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Preoperative Oral Carbohydrates Loading in Patients at High Risk of Postoperative Nausea and Vomiting Undergoing Spinal Surgery
- ClinicalTrials.gov ID
- NCT02809950
- Acronym / sponsor ID
- 4-2015-0984
- Conditions
- Spinal Disease
- Keywords
- postoperative nausea and vomiting, oral carbohydrate beverage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 22 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral carbohydrate beverage group | Experimental | Other: oral carbohydrate beverage |
| control group | Placebo comparator | Other: control group |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- female patient between 20 and 65 of age with ASA physical status Ⅰ-Ⅱ
- patient scheduled for elective spine surgery
- no smoking history
Key exclusion criteria (7 listed)
- hepatorenal disease
- BMI > 35 kg/m2
- gastrointestinal disease
- vomiting within 24h
- administration of antiemetics or opioids within 24 h prior to surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral carbohydrate beverageoral 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 | Other | oral carbohydrate beverage group |
| control groupNPO from midnight of the day before surgery | Other | control group |
Primary outcome
incidence of nausea and vomiting
Time frame: 48 hours
1 secondary outcome
severity of nausea
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing oral carbohydrate beverage in people with Spinal Disease, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin Sun Cho, MD (82-2-2227-0396, chjs0214@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of nausea and vomiting (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2018.