- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07018440
- Original Trial
Low-Volume Oral Carbohydrate Feeding in Bariatric Surgery: Effects on PONV and Recovery
The Effect of Low Volume Oral Carbohydrate Feeding on Nausea, Vomiting and Recovery in Bariatric Surgery Patients: A Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
This randomized controlled trial was designed to evaluate the effects of preoperative low-volume oral carbohydrate loading on postoperative nausea, vomiting, and recovery in patients undergoing bariatric surgery. A total of 105 adult patients scheduled for bariatric surgery were randomized into two groups: an intervention group (n = 53) and a control group (n = 52). The intervention group received 200 mL of a 12.5% carbohydrate solution orally two hours before surgery, while the control group followed standard preoperative fasting protocols without receiving any carbohydrate supplementation.
The primary hypothesis was that preoperative low-volume carbohydrate loading would reduce the frequency and severity of postoperative nausea, vomiting, and retching (PONV), and improve postoperative recovery. Data were collected using validated instruments including the Rhodes Index of Nausea, Vomiting and Retching (RINVR) and the Postoperative Recovery Index (PORI). Outcomes were assessed within 24 hours postoperatively and at postoperative day 30.
Randomization was performed using computer-generated block randomization, and outcome assessment was blinded. The intervention was administered by a trained researcher, and standard postoperative nursing care protocols were applied to both groups.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
İ̇stanbul
-
Istanbul, İ̇stanbul, Turkey, 34722
- Istanbul Education and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥ 18
- Scheduled for bariatric surgery
- ASA score ≤ IV
- Literate in Turkish and able to provide informed consent
Exclusion Criteria:
- Use of antiemetics, steroids, or opioids within 24 hours pre-op
- Need for ICU post-op
- Reoperation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Carbohydrate Feeding Group
Oral administration of 200 ml 12.5% carbohydrate solution 2 hours before surgery.
|
Patients were given Low Volume Oral Carbohydrate feeding (200 mL 12.5% solution) in the preoperative period.
|
|
No Intervention: Control Group
No carbohydrate solution provided; only standard fasting and care applied.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
RINVR Total Score
Time Frame: Day 1
|
RINVR Total Score within 24 hours postoperative
|
Day 1
|
|
PORI Score
Time Frame: Day 30
|
PORI Score at discharge and at 30-day follow-up
|
Day 30
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: HAMDİYE BANU KATRAN, Marmara University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OrCarBariatricNBSN
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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Clinical Trials on Low-Volume Oral Carbohydrate Loading (200 mL of 12.5% solution)
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