Postoperative Recovery Quality According to Preoperative Fasting Time in Pediatric Patients Undergoing Nuss Operation

Jung Min Koo

Status: Unknown

Conditions: Pectus Excavatum

Treatments: Dietary Supplement: New Care No Nil Per Os

Study type: Interventional

Funder types: Other

Identifiers

NCT04068324

KC19ENSI0335

Details and patient eligibility

About

Preoperative fasting is intended to lower the amount of gastric contents in order to decrease the incidence of aspiration associated with endotracheal intubation. However, recent studies show that longer fasting time does not reduce aspiration associated complications. Especially in pediatric patients, long fasting time increases patients' unpleasantness and therefore increases postoperative recovery quality. It also induces hypoglycemia. In many studies, ingesting clear liquids 2 hours up to general anesthesia decreases gastric contents and therefore the incidence of aspiration pneumonia, postoperative nausea and vomiting. Therefore anesthesiologist associations in the US and Europe recommend to drink small amount of clear liquid (water) up to 2 hours before the surgery.

Nuss bar operation, or repair surgery of pectus excavatum is mostly done in pediatric patients. The procedure itself is very painful, requiring paramount amount of analgesics. Use of opioid analgesics increases postoperative nausea and vomiting.

In this study, our aim is to evaluate preoperative fasting time and how preoperative supplement of clear liquid affects the quality of recovery postoperatively.

Enrollment: 90 estimated patients

Sex: All

Ages: 3 to 6 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Pediatric patients from age 3 to 6
2. Undergoing repair surgery for pectus excavatum
3. American Society of Anesthesiologists class I to III

Exclusion criteria

1. Any diseases or past surgical procedures involving gastrointestinal tract
2. Past history of psychiatric diseases
3. On chronic analgesic medication
4. Patients or Patients' caregivers do not agree to attend the study

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

---

90 participants in 3 patient groups

8 hours fasting group

No Intervention group

Description:

Routine preoperative fasting group undergoes 8 hours of fasting before the operation.

Clear liquid group

Experimental group

Description:

30 pediatric patients drink 3ml/kg 1 hour before the surgery. Although "clear liquid" suggests any drinks that do not contain any solid ingredients, but in this study we define "clear liquid" as water.

Treatment:

Dietary Supplement: New Care No Nil Per Os

Carbohydrate containing liquid group

Experimental group

Description:

Other 30 pediatric patients drink 3ml/kg of carbohydrate containing fluid 1 hour before the surgery. The product name we have is "NoNPO" from NewCare (South Korean company). This fluid does not contain any solid ingredients, so consuming the fluid does not exceed Nil per Os time needed before the surgery.

Treatment:

Dietary Supplement: New Care No Nil Per Os