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

NCT07018440 | Completed

• 1 other identifier: OrCarBariatricNBSN
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Bariatric Surgery; Postoperative Nausea and Vomiting

Keywords

Perioperative Nursing; Bariatric Surgery; Postoperative Nausea and Vomiting; Postoperative Recovery; Carbohydrate Feeding

Outcome Measures

Primary Outcomes (2)

• RINVR Total Score

  RINVR Total Score within 24 hours postoperative

  Day 1

• PORI Score

  PORI Score at discharge and at 30-day follow-up

  Day 30

Study Arms (2)

Carbohydrate Feeding Group

EXPERIMENTAL

Oral administration of 200 ml 12.5% carbohydrate solution 2 hours before surgery.

Dietary Supplement: Low-Volume Oral Carbohydrate Loading (200 mL of 12.5% solution)

Control Group

NO INTERVENTION

No carbohydrate solution provided; only standard fasting and care applied.

Interventions

Low-Volume Oral Carbohydrate Loading (200 mL of 12.5% solution) DIETARY_SUPPLEMENT

Patients were given Low Volume Oral Carbohydrate feeding (200 mL 12.5% solution) in the preoperative period.

Carbohydrate Feeding Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18
• Scheduled for bariatric surgery
• ASA score ≤ IV
• Literate in Turkish and able to provide informed consent

You may not qualify if:

• Use of antiemetics, steroids, or opioids within 24 hours pre-op
• Need for ICU post-op
• Reoperation

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Istanbul Education and Research Hospital

Istanbul, İ̇stanbul, 34722, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Solutions

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

• HAMDİYE BANU KATRAN

  Marmara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, no blinding was applied to participants or investigators. However, outcome assessors and statisticians were blinded to group allocation to reduce bias during data analysis.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study used a randomized, parallel-group design with two arms: an intervention group receiving low-volume oral carbohydrate loading before surgery, and a control group receiving standard care. Participants were allocated using computer-generated block randomization, and each participant received only one type of intervention.

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: June 12, 2025
• Study Start: November 1, 2023
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)