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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-19
SponsorUniversity of Malaya

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient diagnosed with idiopathic scoliosis undergoing single-staged posterior spinal fusion

Age between 10 to 19 years old

ASA 1 & 2

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Carbohydrates loadingActive comparator 1 intervention
Group B: Control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Improvement in bowel function by measuring days of first flatus

Numbers of days when patient has start passing flatus post operation

Time frame
From post operation till patient discharge from hospital up to 1 week
2

Improvement in constipation

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

Time frame
From post operation till patient discharge from hospital up to 1 week
3

Post op nausea vomiting

number of nausea and vomiting

Time frame
Post operation within 48hours

Secondary outcomes

1

Length of hospital stay

How many days patient stay in hospital after operation

Time frame
From post operation till patient discharge from hospital up to 1 week
2

anxiety, thirst, hunger

VAS score in operation theatre

Time frame
Before induction of anaesthesia

Other outcomes

1

Gastric residual volume

Ultrasound measurement of gastric residual volume pre- induction

Time frame
Before induction of anaesthesia

Sponsors and contacts

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