Clinical trial NCT06680297: Preoperative Carbohydrate Drink in Adolescent Idiopathic Scoliosis Surgery: the Impact on Safety and Enhanced Recovery
Official title: A Pilot Study on Preoperative Carbohydrate Loading in Adolescent Idiopathic Scoliosis Surgery: the Impact on Safety and Enhanced Recovery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adolescent Idiopathic Scoliosis
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2024-11-08
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Improvement in bowel function by measuring days of first flatus
timeFrame: From post operation till patient discharge from hospital up to 1 week
measure: Improvement in constipation
timeFrame: From post operation till patient discharge from hospital up to 1 week
measure: Post op nausea vomiting
timeFrame: Post operation within 48hours
Secondary outcomes:
measure: Length of hospital stay
timeFrame: From post operation till patient discharge from hospital up to 1 week
measure: anxiety, thirst, hunger
timeFrame: Before induction of anaesthesia
Other outcomes:
measure: Gastric residual volume
timeFrame: Before induction of anaesthesia
Locations:
city: Pantai Valley
country: Malaysia
facility: University Malaya
state: Kuala Lumpur
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
Study officials:
affiliation: Universiti Malaya
name: Siti Nadzrah B Yunus, MBBS
role: PRINCIPAL_INVESTIGATOR
References: