Pectus ExcavatumNCT04068324
Postoperative Recovery Quality According to Preoperative Fasting Time in Pediatric Patients Undergoing Nuss Operation
A study testing New Care No Nil Per Os in people with Pectus Excavatum, run by Jung Min Koo at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Pectus Excavatum
- What is being tested?
- New Care No Nil Per Os
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Aug 2019to 28 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients from age 3 to 6
- Undergoing repair surgery for pectus excavatum
- American Society of Anesthesiologists class I to III
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Jung Min Koo
Seoul
Jung Min Koo, MD, +821051685538, miniyaa623@gmail.com
About this study
Official title: Comparison of Postoperative Recovery After Preoperative Carbohydrate Loading With Standard Fasting in Pediatric Patients Undergoing Nuss Operation
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.
- Conditions
- Pectus Excavatum
- Being tested
- New Care No Nil Per Os
- Medical subject headings
- Funnel Chest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: New Care No Nil Per Os |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 minutes postoperatively at postoperative discharge unit
Secondary outcomes (9)
Pain scores
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.
Measured: Between 1~6 hours postoperatively
Pain scores
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.
Measured: Between 12~24 hours postoperatively
Pain scores
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.
Measured: Between 24~48 hours postoperatively
Other pro re nata analgesics used, amount and type
Analgesics applied in the ward according to the child's pain scale or as requested by his or her parents
Measured: Between 1~6 hours postoperatively
Other pro re nata analgesics used, amount and type
Analgesics applied in the ward according to the child's pain scale or as requested by his or her parents
Measured: Between 12~24 hours postoperatively
Other pro re nata analgesics used, amount and type
Analgesics applied in the ward according to the child's pain scale or as requested by his or her parents
Measured: Between 24~48 hours postoperatively
Any postoperative side effects
Measured: Between 1~6 hours postoperatively
Any postoperative side effects
Measured: Between 12~24 hours postoperatively
Any postoperative side effects
Measured: Between 24~48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start30 Aug 2019
- Primary completion28 Jan 2021 (estimated)
- Study completion28 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pectus ExcavatumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jung Min Koo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jung Min Koo, Seoul St. Mary's Hospital
- Investigators
- Jung Min Koo, MD, Principal investigator, Seoul St. Mary's Hospital, South Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04068324
- Sponsor's protocol ID
- KC19ENSI0335
- Status last verified
- Mar 2020
- First submitted
- 20 Aug 2019
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Recovery After Preoperative Carbohydrate Loading With Standard Fasting in Pediatric Patients Undergoing Nuss Operation
- ClinicalTrials.gov ID
- NCT04068324
- Acronym / sponsor ID
- KC19ENSI0335
- Conditions
- Pectus Excavatum
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Jung Min KooUniversity, hospital or other
- Study start
- 30 Aug 2019 (actual)
- Primary completion
- 28 Jan 2021 (estimated)
- Study completion
- 28 Feb 2021 (estimated)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 8 hours fasting group | No intervention | –Routine preoperative fasting group undergoes 8 hours of fasting before the operation. |
| Clear liquid group | Experimental | Dietary Supplement: New Care No Nil Per Os30 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. |
| Carbohydrate containing liquid group | Experimental | Dietary Supplement: New Care No Nil Per OsOther 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. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Pediatric patients from age 3 to 6
- Undergoing repair surgery for pectus excavatum
- American Society of Anesthesiologists class I to III
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New Care No Nil Per OsThe 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. | Dietary supplement | Carbohydrate containing liquid group, Clear liquid group |
Primary outcome
Modified-Yale Preoperative Anxiety Scale
Time frame: Preoperatively at the surgery waiting room
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.
Emergence delirium
Time frame: 5 Minutes postoperatively at postoperative discharge unit
"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.
Emergence delirium
Time frame: 10 Minutes postoperatively at postoperative discharge unit
"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.
Emergence delirium
Time frame: 15 Minutes postoperatively at postoperative discharge unit
"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.
Emergence delirium
Time frame: 30 Minutes postoperatively at postoperative discharge unit
"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.
Emergence delirium
Time frame: 45 Minutes postoperatively at postoperative discharge unit
"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.
Emergence delirium
Time frame: 60 Minutes postoperatively
"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.
Pain Score
Time frame: 5 minutes postoperatively at postoperative discharge unit
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.
Pain Score
Time frame: 10 minutes postoperatively at postoperative discharge unit
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.
Pain Score
Time frame: 15 minutes postoperatively at postoperative discharge unit
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.
Pain Score
Time frame: 30 minutes postoperatively at postoperative discharge unit
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.
9 secondary outcomes
Pain scores
Time frame: Between 1~6 hours postoperatively
Pain scores
Time frame: Between 12~24 hours postoperatively
Pain scores
Time frame: Between 24~48 hours postoperatively
Other pro re nata analgesics used, amount and type
Time frame: Between 1~6 hours postoperatively
Other pro re nata analgesics used, amount and type
Time frame: Between 12~24 hours postoperatively
Other pro re nata analgesics used, amount and type
Time frame: Between 24~48 hours postoperatively
Any postoperative side effects
Time frame: Between 1~6 hours postoperatively
Any postoperative side effects
Time frame: Between 12~24 hours postoperatively
Any postoperative side effects
Time frame: Between 24~48 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jung Min Koo, MD principal investigator
Seoul St. Mary's Hospital, South Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New Care No Nil Per Os in people with Pectus Excavatum, run by Jung Min Koo at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jung Min Koo, MD (+821051685538, miniyaa623@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified-Yale Preoperative Anxiety Scale (time frame: Preoperatively at the surgery waiting room). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2020.