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

NCT ID: NCT06680297

Last Updated: 2025-05-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-12
• Study Completion Date: 2025-12-31

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.

Conditions

Adolescent Idiopathic Scoliosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Carbohydrates loading

Intervention Type: 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

Participants will undergo standard 6 hrs fasting with 2hr clear water before operation

Group Type: PLACEBO_COMPARATOR

Control group

Intervention Type: 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

Interventions

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.

Intervention Type: 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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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)

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Malaya

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Siti Nadzrah B Yunus, MBBS

Role: PRINCIPAL_INVESTIGATOR

Universiti Malaya

Locations

University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, Malaysia

Site Status: RECRUITING

University Malaya

Pantai Valley, Kuala Lumpur, Malaysia

Site Status: RECRUITING

Countries

Malaysia

Central Contacts

Siti Nadzrah B Yunus, MBBS

Role: CONTACT

siti.nadzrah@ummc.edu.my

0379492052

Facility Contacts

Siti Nadzrah Binti Yunus, MBBS;MAnaes

Role: primary

siti.nadzrah@ummc.edu.my

Siti Nadzrah Yunus, Postgrduate

Role: primary

nadzrahyunus@gmail.com

60176975009

Other Identifiers

1234

Identifier Type: -

Identifier Source: org_study_id