Adolescent Idiopathic ScoliosisCARBO-AISNCT06680297
Preoperative Carbohydrate Drink in Adolescent Idiopathic Scoliosis Surgery: the Impact on Safety and Enhanced Recovery
A study testing Carbohydrates loading in people with Adolescent Idiopathic Scoliosis, run by University of Malaya at 2 sites in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 19 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- Carbohydrates loading
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesMalaysia
- Study dates
- 12 Nov 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient diagnosed with idiopathic scoliosis undergoing single-staged posterior spinal fusion
- Age between 10 to 19 years old
- ASA 1 \& 2
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia2 sites, 2 recruiting
- Recruiting
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 50603
Siti Nadzrah Binti Yunus, MBBS;MAnaes, siti.nadzrah@ummc.edu.my
- Recruiting
University Malaya
Pantai Valley, Kuala Lumpur, 59100
Siti Nadzrah Yunus, Postgrduate, 60176975009, nadzrahyunus@gmail.com
Siti Nadzrah Yunus, Postgraduate
About this study
Official title: 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:
- 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
- Does carbohydrates loading reduces length of hospital stay and patient's overall condition in term of anxiety, thirst and hunger
- Does carbohydrates loading affects gastric residual volume by measuring residual gastric volume with ultrasound
Read the 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.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- Carbohydrates loading, Control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbohydrates loadingDietary 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 groupDietary 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
| Study group | Role | What they receive |
|---|---|---|
| Carbohydrates loading | Active comparator | 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 Receives: Dietary Supplement: Carbohydrates loading |
| Control group | Placebo comparator | Participants will undergo standard 6 hrs fasting with 2hr clear water before operation Receives: Dietary Supplement: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in bowel function by measuring days of first flatus
Numbers of days when patient has start passing flatus post operation
Measured: 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
Measured: From post operation till patient discharge from hospital up to 1 week
Post op nausea vomiting
number of nausea and vomiting
Measured: Post operation within 48hours
Secondary outcomes (2)
Length of hospital stay
How many days patient stay in hospital after operation
Measured: From post operation till patient discharge from hospital up to 1 week
anxiety, thirst, hunger
VAS score in operation theatre
Measured: Before induction of anaesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start12 Nov 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Siti Nadzrah B Yunus, MBBS, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06680297
- Sponsor's protocol ID
- 1234
- Acronym
- CARBO-AIS
- Status last verified
- Jun 2026
- First submitted
- 11 Oct 2024
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study on Preoperative Carbohydrate Loading in Adolescent Idiopathic Scoliosis Surgery: the Impact on Safety and Enhanced Recovery
- ClinicalTrials.gov ID
- NCT06680297
- Acronym / sponsor ID
- CARBO-AIS / 1234
- Conditions
- Adolescent Idiopathic Scoliosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Does carbohydrates loading reduces length of hospital stay and patient's overall condition in term of anxiety, thirst and hunger
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbohydrates loading | Active comparator | Dietary Supplement: Carbohydrates loadingParticipants 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 |
| Control group | Placebo comparator | Dietary Supplement: Control groupParticipants will undergo standard 6 hrs fasting with 2hr clear water before operation |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patient diagnosed with idiopathic scoliosis undergoing single-staged posterior spinal fusion
- Age between 10 to 19 years old
- ASA 1 \& 2
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbohydrates loadingPatient 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 supplement | Carbohydrates loading |
| Control groupPatient assigned to this group will receive standard surgical fasting treatment which include 6hrs of fasting and 2 hrs of clear fluid prior operation | Dietary supplement | Control group |
Primary outcome
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
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
Post op nausea vomiting
Time frame: Post operation within 48hours
number of nausea and vomiting
2 secondary outcomes
Length of hospital stay
Time frame: From post operation till patient discharge from hospital up to 1 week
anxiety, thirst, hunger
Time frame: Before induction of anaesthesia
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Siti Nadzrah B Yunus, MBBS principal investigator
University of Malaya
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbohydrates loading in people with Adolescent Idiopathic Scoliosis, run by University of Malaya at 2 sites in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Siti Nadzrah B Yunus, MBBS (0379492052, siti.nadzrah@ummc.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in bowel function by measuring days of first flatus (time frame: From post operation till patient discharge from hospital up to 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.