Clinical trial NCT04068324: Postoperative Recovery Quality According to Preoperative Fasting Time in Pediatric Patients Undergoing Nuss Operation
Official title: Comparison of Postoperative Recovery After Preoperative Carbohydrate Loading With Standard Fasting in Pediatric Patients Undergoing Nuss Operation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pectus Excavatum
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 90
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Modified-Yale Preoperative Anxiety Scale
timeFrame: Preoperatively at the surgery waiting room
measure: Emergence delirium
timeFrame: 5 Minutes postoperatively at postoperative discharge unit
measure: Emergence delirium
timeFrame: 10 Minutes postoperatively at postoperative discharge unit
measure: Emergence delirium
timeFrame: 15 Minutes postoperatively at postoperative discharge unit
measure: Emergence delirium
timeFrame: 30 Minutes postoperatively at postoperative discharge unit
measure: Emergence delirium
timeFrame: 45 Minutes postoperatively at postoperative discharge unit
measure: Emergence delirium
timeFrame: 60 Minutes postoperatively
measure: Pain Score
timeFrame: 5 minutes postoperatively at postoperative discharge unit
measure: Pain Score
timeFrame: 10 minutes postoperatively at postoperative discharge unit
measure: Pain Score
timeFrame: 15 minutes postoperatively at postoperative discharge unit
measure: Pain Score
timeFrame: 30 minutes postoperatively at postoperative discharge unit
Secondary outcomes:
measure: Pain scores
timeFrame: Between 1~6 hours postoperatively
measure: Pain scores
timeFrame: Between 12~24 hours postoperatively
measure: Pain scores
timeFrame: Between 24~48 hours postoperatively
measure: Other pro re nata analgesics used, amount and type
timeFrame: Between 1~6 hours postoperatively
measure: Other pro re nata analgesics used, amount and type
timeFrame: Between 12~24 hours postoperatively
measure: Other pro re nata analgesics used, amount and type
timeFrame: Between 24~48 hours postoperatively
measure: Any postoperative side effects
timeFrame: Between 1~6 hours postoperatively
measure: Any postoperative side effects
timeFrame: Between 12~24 hours postoperatively
measure: Any postoperative side effects
timeFrame: Between 24~48 hours postoperatively
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jung Min Koo
Study officials:
affiliation: Seoul St. Mary's Hospital, South Korea
name: Jung Min Koo, MD
role: PRINCIPAL_INVESTIGATOR
References: