Preoperative Carbohydrate Drink in Adolescent Idiopathic Scoliosis Surgery: the Impact on Safety and Enhanced Recovery (CARBO-AIS)

A Pilot Study on Preoperative Carbohydrate Loading in Adolescent Idiopathic Scoliosis Surgery: the Impact on Safety and Enhanced Recovery

The goal of this interventional study is to learn if carbohydrates loading improves overall outcome in adolescent patient undergoing scoliosis curgery

The main questions of the study are as follows:

1. Does carbohydrates loading improves gastrointestinal related problems such as improvement in return of bowel function measured by first passage of flatus, reduce constipation by patient's time to first bowel opening and reduce incidence of post post operative nausea and vommiting
2. Does carbohydrates loading reduces length of hospital stay and patient's overall condition in term of anxiety, thirst and hunger
3. Does carbohydrates loading affects gastric residual volume by measuring residual gastric volume with ultrasound

Study Overview

• Status: Recruiting
• Conditions: Adolescent Idiopathic Scoliosis
• Intervention / Treatment: Dietary supplement: Carbohydrates loading; Dietary supplement: Control group

Detailed Description

Preoperative carbohydrate loading is strongly recommended by ESPEN as part of the clinical nutrition in surgery guideline. However, the implementation in clinical setup halted due to several limitations such as cost consuming, unfamiliar with new protocol and lack of expertise. Furthermore, there are no studies for preop carbohydrate loading in AIS as most preop carbohydrate loading is administered as a package for ERAS protocol. Thus, a strong level of evidence is necessary to propel a change in practice. As such, it is important to establish the relationship between carbohydrate loading before surgery and the impact on perioperative outcome.

Understanding the potential benefits of this nutritional intervention in the adolescent scoliosis population could contribute to the ongoing efforts to optimize surgical care in these patients. Although preoperative carbohydrates loading has strong recommendation in spinal fusion ERAS protocol, the level of evident is still scarce, more so in idiopathic scoliosis. In a systematic review, it has also stated that its limitation as most of the literature is largely retrospective studies with non-randomised data and cohort studies lacking formal control groups (Gadiya et al., 2021). Moreover, evidence on other benefits for carbohydrates loading in scoliosis surgery is still lacking such as its impact on pain, return of bowel function and post op nausea and vomiting.

This prospective study seeks to fill this knowledge gap by evaluating the influence of preoperative carbohydrate loading on postoperative outcomes in adolescents undergoing scoliosis surgery. We hypothesize that preoperative carbohydrate loading will be associated with an expedited return of bowel function, a reduced incidence of PONV, a shorter length of hospital stays, improvement in patient general wellbeing and no risk for aspiration. The objectives of this study are threefold. The primary goal of our study is to identify whether there is a significant improvement in the return of bowel function measured by flatus, reducing constipation by days of bowel opening and incidence of postoperative nausea and vomiting for patients receiving carbohydrate loading in comparison with patient that do not receive carbohydrate loading. Secondary objective also include carbohydrate loading and its effect on reducing length of hospital stay undergoing scoliosis surgery as well as patient overall condition in term of thirst, hunger and lethargy. The third objective is to measure the residual gastric volume using ultrasound before induction of anaesthesia.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Siti Nadzrah B Yunus, MBBS; Phone Number: 0379492052; Email: siti.nadzrah@ummc.edu.my

Study Locations

• Malaysia
  • Kuala Lumpur
    • Kuala Lumpur, Kuala Lumpur, Malaysia, 50603
      • Recruiting
      • University Malaya Medical Centre
      • Contact: Siti Nadzrah Binti Yunus, MBBS;MAnaes; Email: siti.nadzrah@ummc.edu.my
    • Pantai Valley, Kuala Lumpur, Malaysia, 59100
      • Recruiting
      • University Malaya
      • Contact: Siti Nadzrah Yunus, Postgrduate; Phone Number: 60176975009; Email: nadzrahyunus@gmail.com
      • Sub-Investigator: Siti Nadzrah Yunus, Postgraduate

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient diagnosed with idiopathic scoliosis undergoing single-staged posterior spinal fusion
• Age between 10 to 19 years old
• ASA 1 & 2

Exclusion Criteria:

• Patient diagnosed with diabetes mellitus (either type I or type II)
• Patient with intellectual disability
• American Society of Anesthesiologists (ASA) class 3 and above
• Significant risk of aspiration (diagnosed with hiatal hernia, presence of GERD, BMI > 35 kg/m2 , poor GCS, swallowing abnormality, gastrointestinal abnormality)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Carbohydrates loading; Participants will be given 10mls/kg of Nestle Resource carbohydrates drink a night before operation and 5mls/kg of Nestle Resource carbohydrates drink 2 hrs before operation	Dietary supplement: Carbohydrates loading; Patient who is randomised in the intervention group will receive Nestle drink 2hours before the operation and a night before operation. They will receive 10mls/kg a night before operation and 5mls/kg 2 hour before operation of the carbohydrate drink.
Placebo Comparator: Control group; Participants will undergo standard 6 hrs fasting with 2hr clear water before operation	Dietary supplement: Control group; Patient assigned to this group will receive standard surgical fasting treatment which include 6hrs of fasting and 2 hrs of clear fluid prior operation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in bowel function by measuring days of first flatus	Numbers of days when patient has start passing flatus post operation	From post operation till patient discharge from hospital up to 1 week
Improvement in constipation	The number of day when patient start to pass motion after operation	From post operation till patient discharge from hospital up to 1 week
Post op nausea vomiting	number of nausea and vomiting	Post operation within 48hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	How many days patient stay in hospital after operation	From post operation till patient discharge from hospital up to 1 week
anxiety, thirst, hunger	VAS score in operation theatre	Before induction of anaesthesia

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastric residual volume	Ultrasound measurement of gastric residual volume pre- induction	Before induction of anaesthesia

Collaborators and Investigators

• Sponsor: University of Malaya
• Investigators: Principal Investigator: Siti Nadzrah B Yunus, MBBS, University of Malaya

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: October 11, 2024
• First Submitted That Met QC Criteria: November 6, 2024
• First Posted (Actual): November 8, 2024

Study Record Updates

• Last Update Posted (Actual): August 20, 2026
• Last Update Submitted That Met QC Criteria: August 18, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Spinal Curvatures; Scoliosis; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID Numbers: 1234 (Department of Defense)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No