NCT04068324

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

August 30, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
Last Updated

March 19, 2020

Status Verified

March 1, 2020

Enrollment Period

1.4 years

First QC Date

August 20, 2019

Last Update Submit

March 18, 2020

Conditions

Pectus Excavatum

Outcome Measures

Primary Outcomes (11)

  • Modified-Yale Preoperative Anxiety Scale

    MyPas scale measures 4 categories: Activity, Vocalizations, Emotional Expressivity and State of Apprent Arousal. Each category has 1 to 4 scales for activity, emotional expresivity and state of apprent arousal, and 1 to 6 for vocalizations, that each describes the child's anxiety status. The observer collects total score ranging from 4 to 18.

    Preoperatively at the surgery waiting room

  • Emergence delirium

    "Watcha scale" measures child's postoperative delirium at the recovery center. The total score ranges from 0 to 4. 0 is when the child is asleep, 1 is calm and sedated, 2 is when the child is crying but consolable, 3 is when the child is crying and unconsolable, and 4 is when the child is uncontrollable.

    5 Minutes postoperatively at postoperative discharge unit

  • Emergence delirium

    "Watcha scale" measures child's postoperative delirium at the recovery center. The total score ranges from 0 to 4. 0 is when the child is asleep, 1 is calm and sedated, 2 is when the child is crying but consolable, 3 is when the child is crying and unconsolable, and 4 is when the child is uncontrollable.

    10 Minutes postoperatively at postoperative discharge unit

  • Emergence delirium

    "Watcha scale" measures child's postoperative delirium at the recovery center. The total score ranges from 0 to 4. 0 is when the child is asleep, 1 is calm and sedated, 2 is when the child is crying but consolable, 3 is when the child is crying and unconsolable, and 4 is when the child is uncontrollable.

    15 Minutes postoperatively at postoperative discharge unit

  • Emergence delirium

    "Watcha scale" measures child's postoperative delirium at the recovery center. The total score ranges from 0 to 4. 0 is when the child is asleep, 1 is calm and sedated, 2 is when the child is crying but consolable, 3 is when the child is crying and unconsolable, and 4 is when the child is uncontrollable.

    30 Minutes postoperatively at postoperative discharge unit

  • Emergence delirium

    "Watcha scale" measures child's postoperative delirium at the recovery center. The total score ranges from 0 to 4. 0 is when the child is asleep, 1 is calm and sedated, 2 is when the child is crying but consolable, 3 is when the child is crying and unconsolable, and 4 is when the child is uncontrollable.

    45 Minutes postoperatively at postoperative discharge unit

  • Emergence delirium

    "Watcha scale" measures child's postoperative delirium at the recovery center. The total score ranges from 0 to 4. 0 is when the child is asleep, 1 is calm and sedated, 2 is when the child is crying but consolable, 3 is when the child is crying and unconsolable, and 4 is when the child is uncontrollable.

    60 Minutes postoperatively

  • Pain Score

    Face, Legs, Activity, Cry and Consolability score: This is a measurement for pediatric pain. The observer observes the child's face, legs, activity, cry and consolability. The score ranges from 0 to maximum of 8. 0 is when the child is calm without any pain, and 8 being the most painful expression of the child.

    5 minutes postoperatively at postoperative discharge unit

  • Pain Score

    Face, Legs, Activity, Cry and Consolability score: This is a measurement for pediatric pain. The observer observes the child's face, legs, activity, cry and consolability. The score ranges from 0 to maximum of 8. 0 is when the child is calm without any pain, and 8 being the most painful expression of the child.

    10 minutes postoperatively at postoperative discharge unit

  • Pain Score

    Face, Legs, Activity, Cry and Consolability score: This is a measurement for pediatric pain. The observer observes the child's face, legs, activity, cry and consolability. The score ranges from 0 to maximum of 8. 0 is when the child is calm without any pain, and 8 being the most painful expression of the child.

    15 minutes postoperatively at postoperative discharge unit

  • Pain Score

    Face, Legs, Activity, Cry and Consolability score: This is a measurement for pediatric pain. The observer observes the child's face, legs, activity, cry and consolability. The score ranges from 0 to maximum of 8. 0 is when the child is calm without any pain, and 8 being the most painful expression of the child.

    30 minutes postoperatively at postoperative discharge unit

Secondary Outcomes (9)

  • Pain scores

    Between 1~6 hours postoperatively

  • Pain scores

    Between 12~24 hours postoperatively

  • Pain scores

    Between 24~48 hours postoperatively

  • Other pro re nata analgesics used, amount and type

    Between 1~6 hours postoperatively

  • Other pro re nata analgesics used, amount and type

    Between 12~24 hours postoperatively

  • +4 more secondary outcomes

Study Arms (3)

8 hours fasting group

NO INTERVENTION

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

Clear liquid group

EXPERIMENTAL

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.

Dietary Supplement: New Care No Nil Per Os

Carbohydrate containing liquid group

EXPERIMENTAL

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.

Dietary Supplement: New Care No Nil Per Os

Interventions

New Care No Nil Per OsDIETARY_SUPPLEMENT

The product name "NoNPO" is from South Korean company "Well life." It contains carbohydrate and is frequently used in preoperative fasting patients in order to alleviate patients' discomfort resulting from empty stomach and thirst. It is also known to decrease insulin resistant.

Carbohydrate containing liquid groupClear liquid group

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jung Min Koo

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Funnel Chest

Condition Hierarchy (Ancestors)

Bone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Jung Min Koo, MD

    Seoul St. Mary's Hospital, South Korea

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jung Min Koo, MD

CONTACT

+821051685538miniyaa623@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 20, 2019

First Posted

August 28, 2019

Study Start

August 30, 2019

Primary Completion

January 28, 2021

Study Completion

February 28, 2021

Last Updated

March 19, 2020

Record last verified: 2020-03

Locations

KR(1)