Clinical trial NCT07018440: Low-Volume Oral Carbohydrate Feeding in Bariatric Surgery: Effects on PONV and Recovery
Official title: The Effect of Low Volume Oral Carbohydrate Feeding on Nausea, Vomiting and Recovery in Bariatric Surgery Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bariatric Surgery
Postoperative Nausea and Vomiting
Keywords: Perioperative Nursing
Bariatric Surgery
Postoperative Nausea and Vomiting
Postoperative Recovery
Carbohydrate Feeding
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2025-06-12
Enrollment: 105
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: RINVR Total Score
timeFrame: Day 1
measure: PORI Score
timeFrame: Day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Education and Research Hospital
state: İ̇stanbul
Study officials:
affiliation: Marmara University
name: HAMDİYE BANU KATRAN
role: PRINCIPAL_INVESTIGATOR
References: