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NCT Number: NCT06680297

Preoperative Carbohydrate Drink 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

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Key information

Age range

10 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Malaya Medical Centre, Kuala Lumpur, Malaysia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Carbohydrates loading

Dietary Supplement

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.

Control group

Dietary Supplement

Patient assigned to this group will receive standard surgical fasting treatment which include 6hrs of fasting and 2 hrs of clear fluid prior operation

Primary outcomes

  1. Improvement in bowel function by measuring days of first flatus

    Time frame: From post operation till patient discharge from hospital up to 1 week

    Numbers of days when patient has start passing flatus post operation

  2. Improvement in constipation

    Time frame: From post operation till patient discharge from hospital up to 1 week

    The number of day when patient start to pass motion after operation

  3. Post op nausea vomiting

    Time frame: Post operation within 48hours

    number of nausea and vomiting

Secondary outcomes

  1. Length of hospital stay

    Time frame: From post operation till patient discharge from hospital up to 1 week

    How many days patient stay in hospital after operation

  2. anxiety, thirst, hunger

    Time frame: Before induction of anaesthesia

    VAS score in operation theatre

Other outcomes

  1. Gastric residual volume

    Time frame: Before induction of anaesthesia

    Ultrasound measurement of gastric residual volume pre- induction

Study contacts

Contact information is provided by the study sponsor or research team.

Siti Nadzrah B Yunus, MBBS

CONTACT

[email protected]

0379492052

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study title

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

Acronym: CARBO-AIS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 8, 2024
Registry last updated
May 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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