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

NCT ID: NCT07018440

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2025-02-28

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).

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.

Conditions

Bariatric Surgery; Postoperative Nausea and Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Carbohydrate Feeding Group

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

Group Type: EXPERIMENTAL

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

Intervention Type: DIETARY_SUPPLEMENT

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

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marmara University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

HAMDİYE BANU KATRAN

Role: PRINCIPAL_INVESTIGATOR

Marmara University

Locations

Istanbul Education and Research Hospital

Istanbul, İ̇stanbul, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

OrCarBariatricNBSN

Identifier Type: -

Identifier Source: org_study_id