Low-Volume Oral Carbohydrate Feeding in Bariatric Surgery: Effects on PONV and Recovery

June 4, 2025 updated by: Marmara University

The Effect of Low Volume Oral Carbohydrate Feeding on Nausea, Vomiting and Recovery in Bariatric Surgery Patients: A Randomized Controlled Trial

This randomized controlled trial aims to evaluate the effects of preoperative oral administration of 200 ml 12.5% carbohydrate solution on postoperative nausea, vomiting, and recovery in bariatric surgery patients. The intervention group received carbohydrate loading two hours before surgery. Outcomes were measured using the Rhodes Index of Nausea, Vomiting and Retching (RINVR) and the Postoperative Recovery Index (PORI).

Study Overview

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

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • İ̇stanbul
      • Istanbul, İ̇stanbul, Turkey, 34722
        • Istanbul Education and Research Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

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: 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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: HAMDİYE BANU KATRAN, Marmara University

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)

November 1, 2023

Primary Completion (Actual)

February 28, 2025

Study Completion (Actual)

February 28, 2025

Study Registration Dates

First Submitted

May 23, 2025

First Submitted That Met QC Criteria

June 4, 2025

First Posted (Actual)

June 12, 2025

Study Record Updates

Last Update Posted (Actual)

June 12, 2025

Last Update Submitted That Met QC Criteria

June 4, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared due to confidentiality concerns and institutional policy.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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