Skip to content

Preoperative Carbohydrate Drink in Adolescent Idiopathic Scoliosis Surgery: the Impact on Safety and Enhanced Recovery

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06680297
Acronym
CARBO-AIS
Enrollment
60
Registered
2024-11-08
Start date
2024-11-12
Completion date
2027-12-31
Last updated
2026-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Idiopathic Scoliosis

Brief summary

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

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.

Interventions

DIETARY_SUPPLEMENTCarbohydrates 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.

DIETARY_SUPPLEMENTControl 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

Sponsors

University of Malaya
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
10 Years to 19 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Improvement in bowel function by measuring days of first flatusFrom post operation till patient discharge from hospital up to 1 weekNumbers of days when patient has start passing flatus post operation
Improvement in constipationFrom post operation till patient discharge from hospital up to 1 weekThe number of day when patient start to pass motion after operation
Post op nausea vomitingPost operation within 48hoursnumber of nausea and vomiting

Secondary

MeasureTime frameDescription
Length of hospital stayFrom post operation till patient discharge from hospital up to 1 weekHow many days patient stay in hospital after operation
anxiety, thirst, hungerBefore induction of anaesthesiaVAS score in operation theatre

Countries

Malaysia

Contacts

CONTACTSiti Nadzrah B Yunus, MBBS
siti.nadzrah@ummc.edu.my0379492052
PRINCIPAL_INVESTIGATORSiti Nadzrah B Yunus, MBBS

University of Malaya

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 21, 2026